Eli Lilly and CompanyLLY along with its partner Incyte Corporation INCY announced that the European Commission has granted marketing authorization to once-daily baricitinib in Europe for the treatment of adults with moderate-to-severe active rheumatoid arthritis (RA). The drug will be marketed by the trade name of Olumiant.
Olumiant (once-daily) is approved as monotherapy or in combination with methotrexate, for the treatment of adult patients who have responded inadequately to, or are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Lilly's share price increased 5.6% year- to -date compared with the Zacks classified Large Cap Pharmaceuticals industry's gain of 1.5%.
This is the first regulatory approval for Olumiant. It is the first JAK inhibitor approved to treat RA in the EU. The drug is under review in the U.S.
The European approval was not much of a surprise considering in Dec 2016, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion on the approval of Olumiant. The CHMP's opinion was based on data from five phase III studies - RA-BEGIN, RA-BEAM, RA-BUILD, RA-BEACON and RA-BEYOND - on the candidate. In the studies, Olumiant demonstrated significant improvement in the signs and symptoms of RA compared to standard of care therapies such as methotrexate and Humira with background methotrexate.
It is estimated that more than 23 million individuals in the world suffer from RA. The disease affects about three times as many women as men. Following approval in EU, Incyte becomes eligible to receive a milestone payment of $65 million from Lilly, which it expects to record in full in the first quarter of 2017.
Lilly and partner Incyte announced in January this year that the FDA has extended the time to review the company's NDA for baricitinib. Previously, the FDA was expected to give a decision early this year. But Lilly submitted additional information on the regulatory agency's request, which the latter deemed a Major Amendment to the NDA. In order to review the additional data, the FDA has extended the Prescription Drug User Fee Act (PDUFA) date by three months.
Eli Lilly and Company Price
Zacks Rank & Key Picks
Lilly currently carries a Zacks Rank #2 (Buy). Some better-ranked stocks in the health care sector include AstraZeneca PLC AZN and GlaxoSmithKline plc GSK . Each of these stocks carries a Zacks Rank #2 (Buy).You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .
AstraZenaca posted a positive earnings surprise in four trailing quarters with an average beat of 117.05%. Its share price increased 2.5% year to date.
GlaxoSmithKline's earnings estimates increased from $2.66 to $2.72 for 2017 and from $2.80 to $2.84 for 2018 over the last seven days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 11.03%. Its share price increased 4.4% year to date.
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