Eli Lilly and Company LLY announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for a conditional marketing authorization of olaratumab in the treatment of advanced soft tissue sarcoma (STS).
Eli Lilly is looking to get olaratumab approved, in combination with doxorubicin, for the treatment of adults with advanced STS, not amenable to curative treatment with radiotherapy or surgery and who have not been previously treated with doxorubicin.
Note that the European Commission (EC) generally takes the CHMP’s opinion into account while reviewing drug applications but is not bound to abide by the same. A final decision from the EC should be out within the next three months. The product will be marketed under the trade name Lartruvo, upon approval.
The submission of a Marketing Authorisation Application (MAA) in the EU was based on data from the phase II JGDG study on olaratumab. However, the conditional marketing authorization requires Eli Lilly to provide results from an ongoing phase III study, ANNOUNCE.
We remind investor that olaratumab is also under review in the U.S. The FDA has granted Priority Review status for the candidate.
Olaratumab enjoys Orphan Drug status for the treatment of STS both in the U.S. and the EU. The candidate also has Breakthrough Therapy and Fast Track designation in the U.S.
According to information provided by the company, 23,000 people have been estimated to be diagnosed with STS in the EU in 2016.
Eli Lilly currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Pacira Pharmaceuticals, Inc. PCRX, Corcept Therapeutics Incorporated CORT and ANI Pharmaceuticals, Inc. ANIP. All three stocks sport a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>
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
To read this article on Zacks.com click here.
Zacks Investment Research