Shares of Incyte Corporation INCY declined 1.9% after the FDA extended the review period of the supplemental New Drug Application (sNDA) for Jakafi to treat patients with acute graft-versus-host disease (GVHD) who have had an inadequate response to corticosteroids.
The sNDA for the treatment of patients with acute GVHD was submitted in August 2018, and the FDA granted it both Priority Review and Breakthrough Therapy designation.
However, the FDA extended the action date by three months to review additional data submitted by Incyte in response to the FDA’s information requests. The additional data has been determined by the FDA to constitute a major amendment to the sNDA,
Hence, the new Prescription Drug User Fee Act (PDUFA) target action date is May 24, 2019.
The news comes as a disappointment for the company, as a label expansion of the drug would have boosted sales.
We remind investors that Jakafi, a first-in-class JAK1/JAK2 inhibitor, is already approved by the FDA for the treatment of people with polycythemiavera (PV) who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is also indicated for the treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemiavera MF and post–essential thrombocythemia MF.
The drug is marketed by Incyte in the United States and by Novartis NVS as Jakavi outside the United States.
Meanwhile, Jakafi is also being evaluated in patients with acute and chronic GVHD who have an inadequate response to corticosteroids in the REACH2 and REACH3 clinical studies, respectively. Both the studies are expected to be completed in 2019, and could support additional regulatory submissions in 2020.
Earlier in the week, Eli Lilly and Company LLY and Incyte Corporation announced positive top-line data from two late-stage studies, evaluating their oral JAK inhibitor, Olumiant (baricitinib) as monotherapy for moderate-to-severe atopic dermatitis (“AD”), a type of eczema. Data from the phase III studies — BREEZE-AD1 and BREEZE-AD2 — showed that the candidate met the primary endpoints of statistically significant improvements in patients compared to placebo, as measured by Investigator's Global Assessment for AD (“IGA”) score after treatment of 16 weeks.
Incyte’s stock has lost 5.5% in the past year compared with the industry’s 16.5% decline. We remind investors that the company suffered a huge setback with the failure of the phase III study, ECHO-301, as it was one of the most promising candidates for Incyte, evaluating epacadostat in combination with Merck’s MRK Keytruda.