INCYTE COVID-19 Response

Updated September 2, 2020

As a global biopharmaceutical company, Incyte takes public health very seriously, and we are closely monitoring the evolving COVID-19 pandemic. Our primary focus is on ensuring patients have access to the medicines they need while safeguarding the health and safety of our employees.

See our responses to frequently asked questions below regarding how Incyte is responding to COVID-19. Please contact our support resources, listed below, for more information.

 

Incyte Medicines

We encourage patients to first discuss any questions or concerns regarding their existing treatments with their healthcare providers, as they are best informed about the specific healthcare needs of their patients and the potential risks associated with discontinuing or modifying treatment.

In the United States, patients with questions can contact Incyte’s U.S. Medical Information line at 1-855-4MED-INFO (1-855-463-3463) or send an email to medinfo@Incyte.com.

Outside the United States patients can call +800-0002-7423 or send an email to globalmedinfo@incyte.com or eumedinfo@incyte.com.

Additionally, eligible patients in the United States who are currently prescribed Jakafi® (ruxolitinib) can contact IncyteCARES (Connecting to Access, Reimbursement, Education and Support), a comprehensive program offering patient support, including financial assistance and ongoing education and resources for eligible patients.

More information about IncyteCARES is available by visiting www.incytecares.com or calling 1-855-4-Jakafi (855-452-5234).

We are focused on ensuring all patients have access to the medicines they need, including clinical trial participants. At present, our clinical trials around the world are proceeding as we monitor the situation closely to ensure continuity of care for all individuals participating in our studies and data integrity.

We are working closely with our study sites and vendor partners on continuity of investigational product supply, and conducting and monitoring the studies in accordance with existing and emerging Good Clinical Practice (GCP) guidance from global regulatory agencies. We are preparing contingency plans including notifying relevant stakeholders should that be needed. Study participants can contact their healthcare provider for more information.

Research for COVID-19

Yes, there are several ongoing or planned studies of ruxolitinib in patients with COVID-19: 

  • In April 2020, we announced the initiation of RUXCOVID (NCT04362137), a global, randomized, double-blind, placebo-controlled 29-day, multi-center, Phase 3 clinical trial evaluating the efficacy and safety of ruxolitinib (Jakafi®) plus standard-of-care (SoC) in patients aged ≥12 years with COVID-19 associated cytokine storm. The collaborative study is sponsored by Incyte in the United States and Novartis outside of the United States. For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT04362137.
  • Incyte is also opening a second Phase 3 clinical trial (369 DEVENT) in the United States to evaluate the efficacy and safety of ruxolitinib plus SoC, compared to SoC therapy in patients with COVID-19 on mechanical ventilation and who have acute respiratory distress syndrome (ARDS), a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs.
  • Additionally, given the urgent nature of the COVID-19 pandemic, we have initiated a separate emergency Expanded Access Program (EAP) (NCT04355793) in the United States. The protocol will allow eligible patients with severe COVID-19 associated cytokine storm to receive ruxolitinib while it is being investigated for this indication. For more information about the EAP, please visit: https://clinicaltrials.gov/ct2/show/NCT04355793.

For more details, see our press release here.

Cytokine storm is a severe immune overreaction that can be triggered by viral infection and can lead to serious complications, including
pneumonia and acute respiratory distress syndrome (ARDS). Patients with COVID-19 associated cytokine storm who experience these
complications often require intensive care, including intubation and the use of mechanical ventilation, and are at an increased risk of
mortality.

To view the Anatomy of a Cytokine Storm, please see:

Cytokine storm is a severe immune overreaction that can be triggered by viral infection and can lead to serious complications, including pneumonia and acute respiratory distress syndrome (ARDS). Patients with COVID-19 associated cytokine storm who experience these complications often require intensive care, including intubation and the use of mechanical ventilation, and are at an increased risk of mortality.

Emerging evidence suggests regulating overactive signaling through the JAK-STAT pathway during a cytokine storm associated with COVID-19 could be a potential treatment approach, and it is hypothesized that ruxolitinib, a JAK1/JAK2 inhibitor, may be able to play a role in treating these patients.

A review article titled ‘Inhibition of Cytokine Signaling by Ruxolitinib and Implications for COVID-19 Treatment’ published in Clinical Immunology summarizes existing preclinical and clinical data on ruxolitinib in inflammatory conditions and outlines the hypothesized mechanism of ruxolitinib in COVID-19 associated cytokine storm.

Currently, there is limited evidence on the safety or efficacy of ruxolitinib in the clinical treatment of COVID-19 and ruxolitinib is not currently FDA-approved for this use. Please view U.S. Prescribing Information at www.jakafi.com.

RUXCOVID (NCT04362137) is a global, randomized, double-blind, placebo-controlled, 29-day, multi-center, Phase 3 study evaluating the efficacy and safety of ruxolitinib (Jakafi®)  plus standard of care (SoC) therapy in patients aged ≥12 years with COVID-19 associated cytokine storm compared to placebo plus SoC therapy. The study will enroll approximately 400 patients globally.

The composite primary endpoint is the proportion of patients who die, develop respiratory failure (require mechanical ventilation), or require intensive care unit (ICU) care by Day 29. Secondary endpoints are comprised of various efficacy assessments including evaluation of clinical status using a 9-point ordinal scale; in-hospital outcomes including mortality rate, proportion of patients requiring mechanical ventilation, duration of hospitalization, ICU stay, supplemental oxygen and/or invasive mechanical ventilation; change in the National Early Warning Score (NEWS2); change in SpO2/FiO2 ratio; proportion of patients with no oxygen therapy (oxygen saturation of ≥94% on room air); and safety.

Eligible patients will be randomized 2:1 to receive oral ruxolitinib 5mg twice daily (BID) or oral-matching placebo for a total of 14 days. Study treatment will be given in combination with SoC therapy according to the investigator’s clinical judgement. After 14 days of therapy, should clinical signs or symptoms not improve or worsen, patients may receive an additional 14 days of study therapy. In total, patients will be followed on study for 29 days post-randomization.

The RUXCOVID study is sponsored by Incyte in the United States, and Novartis outside of the United States. For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT04362137.

369 DEVENT (NCT04377620), is a randomized, double-blind, placebo-controlled, 29-day, multi-center, Phase 3 study evaluating the efficacy and safety of ruxolitinib (Jakafi®) plus standard of care (SoC) therapy in patients aged ≥18 years with COVID-19, on mechanical ventilation and who have acute respiratory distress syndrome (ARDS). ARDS is a type of respiratory failure characterized by the rapid onset of widespread inflammation in the lungs. The study will enroll approximately 500 patients in the U.S.

The primary endpoint is overall survival through Day 29. Secondary endpoints include in-hospital outcomes (ventilator-free, ICU-free, oxygen-free, vasopressor-free, hospital-free days at Day 29); efficacy using a 9-point ordinal scale at Days 15 and 29; change from baseline in SOFA score at various time points; and safety.

Eligible patients will be randomized 2:2:1 to receive oral ruxolitinib 5mg twice daily (BID), 15mg BID or oral-matching placebo for a total of 14 days. Study treatment will be given in combination with SoC therapy according to the investigator’s clinical judgement. On Day 15, if the investigator believes it is appropriate, continued treatment up to 28 days with study therapy is permitted with medical monitor approval. In total, patients will be followed on study for 29 days post-randomization.

The 369 DEVENT study is sponsored by Incyte. For more information, please visit https://clinicaltrials.gov/ct2/show/NCT04377620?term=NCT04377620&draw=2&rank=1.

The ruxolitinib Expanded Access Program (EAP) in COVID-19 for patients with severe COVID-19 associated cytokine storm (NCT04355793) allows eligible patients to receive ruxolitinib while it is being investigated in COVID-19 patients. Patients must be unable to participate in other clinical trials of ruxolitinib in COVID-19 to qualify for this EAP. For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT04355793.

Questions or inquiries regarding the EAP should be made to:

U.S. Medical Information

1-855-4MED-INFO (1-855-463-3463)

medinfo@incyte.com

Questions or inquiries regarding the RUXCOVID study, 369 DEVENT study or Expanded Access Program should be made to:

U.S. Medical Information

1-888-4MED-INFO (1-855-463-3463)

medinfo@incyte.com

Through our Investigator Initiated Research (IIR) program, we are expediting review of requests for ruxolitinib made by U.S. investigators for COVID‑19‑related indications and evaluating requests for our other compounds globally.

The Incyte IIR program is open to physicians, researchers and institutions interested in conducting external research. For questions or inquiries, please contact US_IIR@incyte.com in the United States and Global_IIR@incyte.com outside of the United States.

View country-specific contact information here.

For more information regarding the Incyte U.S. IIR program, visit: iir.incyte.com.

We are aware of a number of investigator-initiated studies and case reports of ruxolitinib in patients with COVID-19. Data from some of these have been or are expected to be published in peer-reviewed medical journals, including the following:

  • Researchers from the Tongji Hospital, Huazhong University of Science and Technology in Wuhan, China, have conducted a prospective, multicenter, single-blind, randomized controlled Phase 2 study evaluating the efficacy and safety of ruxolitinib in patients with severe COVID-19. Results from this study were published in the Journal of Allergy and Clinical Immunology on May 26, 2020, and are available here. Additional details can also be found in the Company Statement issued by Incyte.
  • As part of Incyte’s emergency IND program, four patients with severe COVID-19 and Acute Respiratory Distress Syndrome (ARDS) were treated with ruxolitinib at the Yale New Haven Hospital. Results from this experience have been submitted to Circulation and are available on a preprint server at: https://ssrn.com/abstract=3606658
  • A retrospective chart analysis of fourteen COVID-19 patients with severe systemic hyperinflammation who received ruxolitinib at the Schwarzwald-Baar-Klinikum, Villingen-Schwenningen, Germany has been published in Leukemia and is available here.
  • A report on a prospective, observational study of 34 patients with COVID-19 who received ruxolitinib as part of the Novartis compassionate use program has been published in Leukemia by the RUXO-COVID Study Group in Florence, Italy and is available here.

Please note, there is limited evidence on the safety or efficacy of ruxolitinib in the clinical treatment of COVID-19 and ruxolitinib is not currently FDA-approved for this use. Please view U.S. Prescribing Information at www.jakafi.com.

 

Supply Chain & Distribution

At present, we have ample commercial and clinical supply of our medicines to meet the needs of patients receiving our approved medicines and those participating in our global clinical trials. The global COVID-19 outbreak has not had any impact on Incyte’s supply chain to-date, and we are working diligently to increase our manufacturing efforts in response to the COVID-19 pandemic.

At present, we have ample commercial and clinical supply of our medicines to meet the needs of patients receiving our approved medicines and those participating in our global clinical trials. The global COVID-19 outbreak has not had any impact on Incyte’s supply chain to-date, and we are working diligently to increase our manufacturing efforts in response to the COVID-19 pandemic.

Incyte is working closely with distribution partners to monitor supply of Jakafi and ensure safeguards are in place and will work rapidly to make sure that patients continue to have access to Jakafi that has been prescribed to them.

Additionally, we have taken precautions by ensuring that our current inventory of approved and investigational medicines is stored in different locations across the United States and Europe should one specific region or warehouse face a disruption.

Community Support

Incyte is committed to supporting the local communities where we live and work, particularly during this unprecedented time of need.

Incyte has made several contributions, including:

  • Supplies, including personal protective equipment (PPE), from Incyte’s laboratories in Wilmington, DE, have been donated to local Delaware hospitals, with plans to continue providing supplies, as we are able.
  • Incyte has also donated to the Food Bank of Delaware to cover the costs of increased food distribution and pre-made weekend meal kits. 
  • Incyte Italy has made a donation to fund the purchase of hospital equipment and goods to support patients, hospitals, healthcare facilities and providers in the critically affected Lombardy region. 
  • Along with other companies, Incyte supported The Leukemia & Lymphoma Society COVID-19 Patient Financial Aid program, aimed at providing financial assistance to eligible patients for food, non-medical and other day-to-day expenses that may arise due to loss of income.

We know that needs will continue to emerge over the coming weeks and months, and we will continue to maintain close contact with our community partners and consider additional opportunities to provide support.

During these unprecedented times, we send our gratitude to the many healthcare providers on the frontlines of this outbreak, and our support to all those affected by this virus.

We have received requests for donations of personal protective equipment (PPE), such as masks, goggles, gloves and gowns, from hospitals and other healthcare institutions. We have donated supplies, including PPE, from our laboratories in Wilmington, DE, to local hospitals, with plans to continue providing supplies, as we are able.

Additionally, Incyte Italy has made a donation to fund the purchase of hospital equipment and goods to support patients, hospitals, healthcare facilities and providers in the critically affected Lombardy region.

We are continuing to evaluate opportunities to provide additional assistance.

Our People and Offices

We take the health and safety of our employees, their families and our local communities very seriously, and are closely monitoring the evolving COVID-19 pandemic. As such, we have put several measures in place to prepare for and protect against the transmission of COVID-19 in our facilities around the world and ensure we have the tools we need to support our work to serve patients. This includes:

  • Requiring those who are able to work from home to do so, and restricting access to our offices and laboratories to only the personnel needed to carry out essential business continuity activities.
  • Implementing additional cleanings throughout our campuses to help protect those who continue to work on site.
  • Suspending all visitor access. 
  • Replacing in-person interactions with virtual meetings so that our employees can safely continue to meet the needs of patients and healthcare providers.
  • Restricting all global and domestic company air travel to trips that support essential business continuity.
  • Cancelling/postponing all in-person Incyte meetings and events.
  • Working closely with appropriate health authorities and fully complying with all Centers for Disease Control and Prevention (CDC), World Health Organization (WHO) and applicable local government regulations and protocols.

 

Resources

For Patients and Healthcare Professionals

For general questions please click here.

Inquiries about Incyte products or clinical trials should be directed to Incyte Medical Information:

Learn More About COVID-19

Centers for Disease Control and Prevention (CDC) Website

World Health Organization (WHO) Website

For Wholesalers and Distributors with Product/Supply Questions

In the United States email​ Incyte_TradeandDistribution@incyte.com

Outside the United States email IncyteEUSupplyChain@incyte.com

For Media

Media inquiries can be submitted here or via email at media@incyte.com

For Investors

Investor inquiries can be sent to ir@incyte.com