Incyte Corporation (INCY - Free Report) announced that the FDA has approved a label expansion of its lead drug, Jakafi (ruxolitinib).
Jakafi is now approved for the treatment of steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients aged 12 years or older.
The approval was based on encouraging data from REACH1, an open-label, single-arm, multicenter study of Jakafi in combination with corticosteroids in patients with steroid-refractory grade II-IV acute GVHD.
The FDA had earlier granted Breakthrough Therapy designation and Orphan Drug status to Jakafi for the treatment of patients with steroid-refractory acute GVHD. The supplemental New Drug Application (sNDA) was reviewed under the FDA’s Priority Review program.
Per Incyte, this is the first and only FDA-approved treatment for the aforementioned indication.
GVHD is a condition that affects a person after an allogeneic stem cell transplant (the transfer of stem cells from a donor), where the donated cells initiate an immune response and attack the transplant recipient’s organs. This leads to significant morbidity and mortality.
The approval should relieve the investors as the FDA had earlier extended the review period of the sNDA.
Incyte’s stock has rallied 28.6% in the year so far compared with 2.1% growth for the industry.
Jakafi, a first-in-class JAK1/JAK2 inhibitor, is approved in the United States for the treatment of patients with polycythemia vera (“PV”), who have had an inadequate response to or are intolerant to hydroxyurea. The drug is also approved for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-PV MF and post-essential thrombocythemia MF.
This is the third indication, for which the drug has been approved in the United States. The label expansion of Jakafi will further boost sales of. Incyte is working to expand the drug’s label further into additional indications. The REACH2 and REACH3 trials, evaluating steroid-refractory acute and steroid-refractory chronic GVHD, respectively, are ongoing in collaboration with Novartis (NVS - Free Report) . Data from these studies are expected later in the year.
Incyte’s efforts to develop its pipeline is highly encouraging. The company has elected to not participate in the development of baricitinib with Eli Lilly (LLY - Free Report) in order to reallocate capital, over time, to other promising internal projects. The company has some very promising candidates, including pemigatinib, itacitinib and capmatinib, among others, in its pipeline. Though we are pleased with Incyte’s broad pipeline, the recent setbacks are a concern. The company suffered a setback with the failure of a late-stage study, evaluating epacadostat in combination with Merck’s (MRK - Free Report) Keytruda.
Incyte currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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