Patients

Incyte is committed to positively impacting the lives of patients with cancer and autoimmune and inflammatory diseases. We believe in the power of research to advance scientific innovation and improve patient health. To learn more about Incyte clinical trials, please click here.

 

Access to Medicine

Clinical Trials

Incyte sincerely appreciates all the patient volunteers who participate in clinical trials and help make new medical treatments possible. Incyte is committed to helping eligible patients gain access to appropriate treatments through the discovery and development of new therapies. We believe that conducting clinical trials under the review of global regulatory authorities to obtain the necessary approvals provides patients with an important mechanism for increased access to medicines as prescribed by qualified healthcare professionals. We understand that some patients may be eligible to participate in an Incyte-sponsored clinical trial involving an investigational product but may not have the resources to participate. We are committed to ensuring that eligible patients have access to applicable clinical trials by providing them with information and resources to support their treatment journeys, consistent with applicable laws, regulations and ethical guidelines.

Expanded Access

We recognize that some patients with serious or immediately life threatening diseases may not be eligible for participation in a clinical trial or may not have other options. Subject to appropriate internal review and approval based on the conditions in Incyte's Policy on Compassionate Use, Incyte may choose to provide individual patients with access to an unapproved or investigational product outside of a clinical trial setting through expanded access, including through the use of single patient investigational new drug (SPIND) applications or on a named patient basis. For more information, please click here for our Policy on Compassionate Use.

Access to Approved Medicines

Incyte seeks to ensure that eligible patients in the U.S. are able to access and afford our approved medicines. We are supportive of legislation that would reduce out-of-pocket costs and remove barriers to access to innovative medicines.

Incyte supports patient access and an example of that is IncyteCARES. Our IncyteCARES (Connecting to Access, Reimbursement, Education and Support) program supports eligible privately or uninsured patients in the U.S. before and during applicable treatment with Jakafi® (ruxolitinib) and PemazyreTM (pemigatinib) through ongoing support and education with dedicated nurses, and patient access coordinators. IncyteCARES services include copay/coinsurance assistance for eligible commercially insured patients, free product assistance for eligible patients who are uninsured or who experience temporary coverage delays, reimbursement support through benefit verifications and clinical education support to patients about their condition and use of the medicine they are receiving. For more information, please click here.

"We try and set the highest standard that we can so that we can move forward at a faster rate, a faster pace, but still doing the right science. So it still all comes back to the science, doing the right thing at the right time with the right people. What we say quite often in the lab is, ‘Individual success equals team success, equals Incyte success, and ultimately equals patient success.’"

—Maryanne Covington, Director, Pharmacology

Patient Education and Awareness

Incyte is committed to providing patients with resources to support their treatment journey. This is particularly important as our products, Jakafi® (ruxolitinib), Iclusig®(ponatinib) and PemazyreTM (pemigatinib)1 are approved  to treat rare diseases. Patients with rare diseases often have difficulty in finding support from other patients with the same disease or educational resources about their disease.

Myeloproliferative Neoplasms (MPNs)

For patients living with MPNs, Incyte created Voices of MPN, a U.S. website and community focused on connecting MPN patients to information, educational programs and community activities as well as to provide a forum where people can share stories and promote disease awareness. To learn more about our efforts, please click here.

Each year, in partnership with CURE Media Group, publishers of CURE® magazine, Incyte sponsors the MPN Heroes® Recognition Program, which honors and celebrates individuals and organizations for their contributions in caregiving, community leadership or scientific advances in the MPN community. To learn more about this recognition program, please click here.

Graft-Versus-Host Disease (GVHD)

Incyte launched the Incyte Ingenuity Award, which aims to support innovative ideas to improve the care and treatment of the GVHD community in the U.S. by providing funding for an activity, idea or initiative annually that addresses a need for people impacted by GVHD. With the launch of the Incyte Ingenuity Award, we hope to address some of the many challenges that GVHD patients, caregivers and healthcare providers face in managing this disease by fostering collaboration within the GVHD community. For more information, please click here.

Chronic Myeloid Leukemia (CML)

In 2018, Incyte launched CML Life, a patient support website for patients in Europe suffering from CML, regardless of their treatment or their stage of disease. CML Life seeks to help patients, caregivers and heath care professionals better understand and manage CML from diagnosis to treatment, with the goal of facilitating treatment engagement and adherence. This program has been co-created and co-developed with both patients and health care professionals. For more information, please click here.

 

R&D Excellence

We hold our clinical research to the highest scientific and ethical standards. We execute on these standards through our rigorous discovery process and our adherence to good clinical practices and clinical trial standards set by the FDA, EMA, PMDA and other international regulatory bodies. Incyte is committed to acting ethically and responsibly and applying high standards of care when conducting preclinical research both internally and at third-party institutions. Incyte’s facility is AAALAC International accredited, and wherever possible, we work with third parties accredited by AAALAC International. We focus on data transparency by presenting study data, regardless of outcome, at appropriate medical meetings and in peer-reviewed journals. To learn more, please see our Clinical Trial Transparency, Data Sharing and Disclosure Practices here.

Our Focus on New Therapies

Our portfolio speaks to our commitment to improving the treatment of serious diseases like cancer and inflammatory and autoimmune diseases.

In oncology, we have 3 discovery platforms: small molecule, monoclonal antibody, and bispecific antibody capabilities. We believe that this multifaceted approach positions us well as we seek to utilize these different treatment modalities to evaluate development candidates across a diverse spectrum of therapeutic targets.

The goal of Incyte’s Inflammation and Autoimmunity (IAI) development group is to identify, target and modulate immunological pathways driving uncontrolled inflammation and the destruction of the body’s own cells and tissues. In doing so, we hope to restore normal immune function to bring the body closer to homeostasis. Our IAI team utilizes their broad immunological understanding of disease and cross functional knowledge of our programs to identify innovative approaches to treating inflammatory and autoimmune diseases.

Partnering

As the effort to bring transformative treatments to patients is a significant undertaking, we are committed to partnering with companies, universities, and research institutions in order to share knowledge, resources, and ideas that may best benefit patients. 

lncyte may also provide our investigational products and/or financial support for independent research by third parties in therapeutic areas of interest. We are committed to ensuring that requests for investigator-initiated research (IIRs) are submitted, reviewed, and, if approved, conducted and funded in a standardized and consistent manner. Incyte seeks to ensure that our interactions with study investigators comply with all applicable legal and ethical standards and obligations.

Results

Our commitment to patients through scientific excellence has resulted in FDA approved products, including for the treatment of diseases where there were no prior therapies approved. Jakafi® (ruxolitinib) was the first FDA-approved JAK inhibitor for any indication and was the first FDA-approved product in all three of its current indications. Pemazyre (pemigatinib) was also approved1 by the FDA in an indication where there were no approved therapies for patients. 

We acquired the right to Iclusig® (ponatinib) through an exclusive license from Takeda Pharmaceuticals International in the European Union and 29 other countries, including Switzerland, Norway, Turkey, Israel and Russia. Beyond our in-house development portfolio, Incyte scientists discovered two additional approved medicines, Olumiant® (baricitinib), developed and commercialized by our partner Eli Lilly, and Tabrecta (capmatinib), developed and commercialized by our partner Novartis. 

Because our commitment to patients is our top priority, a significant portion of our revenue is reinvested back into R&D to support the discovery and development of new therapies for patients in need.
 

Patient Safety

Clinical Trials

Incyte values the patient volunteers who participate in clinical trials, and patient safety is a top priority at Incyte. We believe that patient safety is best served by conducting clinical trials to study safety and efficacy of investigational medicines to allow thorough review by the FDA, EMA, PMDA and other international regulatory bodies. Clinical trials are essential to the safe use of our products, and our trials are conducted with patient safety as our primary focus. As such, we are committed to adhering to the applicable laws and regulations in all territories in which we operate clinical trials and to conducting trials in an ethical manner. In doing so, we carefully consider both the potential benefits as well as the risks of each trial before deciding to proceed. We then have protocols in place to obtain informed consent from patients participating in our clinical trials.

Most pivotal clinical trials intended to support applications for the approval of investigational products proceed to full completion of planned sample size accrual. Certain drug development plans include the requirement to access interim data for a variety of reasons, such as ensuring participant safety. Incyte is committed to the supervision of all ongoing trials through an institutional review board, an ethics committee, and/or a research ethics board in order to protect the safety of trial participants.

As a matter of transparency and ethics, Incyte is committed to announcing applicable trial results, positive or negative, on clinicaltrials.gov in the U.S. and/or other applicable registries, at appropriate medical meetings, and in peer-reviewed journals in a timely manner. Publication of these data are scientifically responsible and may serve to benefit both patients as well as the entire scientific community as we collectively seek to transform the treatment of cancer and other diseases, and we therefore seek to publish data within 18 months from the last patient leaving the study. Please see our Clinical Trial Transparency, Data Sharing and Disclosure Practices here.

Product Serialization and Anti-Counterfeiting

Anti-counterfeiting measures and product serialization are in place to increase patient safety as well as to address regulatory requirements, thus ensuring Incyte’s compliance, patients’ safety and security.

Two kinds of anti-counterfeiting features, overt and covert, are currently in place for Incyte medicines. Overt features are for patients, healthcare providers and regulatory authorities to authenticate the product and, as such, make medicines difficult to reproduce. To further avoid fake or counterfeit product, overt features are combined with tamper evident packaging. Covert features are intended for a restricted number of Incyte's personnel to quickly authenticate products in the event of suspected counterfeiting.

Suspected counterfeit issues or claims related to our products are handled internally via Incyte’s Material Review Boards (MRB) and the Falsified Drug Product Committee (FDPC).  The MRB is a Quality Assurance (QA) forum. In the event of a suspected counterfeit issue, the QA chair communicates with his/her QA business partner counterpart to determine the potential impact on product safety and the need for any related regulatory or other action. The FDPC is a cross-functional team, chaired by the Head of Supply Chain.  The FDPC team includes representation from Supply Chain, QA, Communications, Legal and Regulatory Affairs.  The FDPC convenes meetings internally and externally to share information and align on necessary actions, including communication to external stakeholders.  External communications have historically been disseminated by alerts from the WHO via its website and communications portal with health authorities, with Company Statements, including relevant information and contact details, being made available via the Incyte corporate website.

Related to serialization, a single identifier is printed on each product pack along with a 2D barcode with encoded information and an anti-tampering device. At delivery to the patient and at any dispensing point, the pack can then be scanned to confirm its authenticity.

 

1. Pemazyre received accelerated approval from the FDA in April 2020 and continued approval may be contingent on verification and description of clinical benefit in a confirmatory trial(s).