Lilly's Olumiant Gets Marketing Authorization in Europe

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

Eli Lilly and Company Price | Eli Lilly and Company Quote

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.

The Best Place to Start Your Stock Search

Today, you are invited to download the full list of 220 Zacks Rank #1 ""Strong Buy"" stocks - absolutely free of charge. Since 1988, Zacks Rank #1 stocks have nearly tripled the market, with average gains of +26% per year. Plus, you can access the list of portfolio-killing Zacks Rank #5 ""Strong Sells"" and other private research. See these stocks free >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Astrazeneca PLC (AZN): Free Stock Analysis Report

Eli Lilly and Company (LLY): Free Stock Analysis Report

GlaxoSmithKline PLC (GSK): Free Stock Analysis Report

Incyte Corporation (INCY): Free Stock Analysis Report

To read this article on click here.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

In This Story


Other Topics


Latest Markets Videos


Zacks is the leading investment research firm focusing on stock research, analysis and recommendations. In 1978, our founder discovered the power of earnings estimate revisions to enable profitable investment decisions. Today, that discovery is still the heart of the Zacks Rank. A wealth of resources for individual investors is available at

Learn More