Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended expanding Trisenox’s label in the EU. The company is looking to get Trisenox approved in combination with retinoic acid for the treatment of low to intermediate risk acute promyelocytic leukemia (APL).
The positive CHMP opinion was based on the existing academic data on the benefit of this chemotherapy-free treatment regimen. With the CHMP issuing a positive opinion, chances of gaining EU approval for expanded use appear high. A decision should be out by the end of the year.
Trisenox’s approval for expanded use would make it the first time for a form of acute leukemia to be effectively treated with a regimen that is completely chemotherapy-free.
Note that Trisenox is currently approved for the second-line treatment of APL patients who have not responded to treatment with retinoids and chemotherapy, or when their disease has returned after this type of treatment.
Per the company’s press release, APL is a rare and aggressive type of acute leukemia with around 1,500 to 2,000 diagnosed with the disease annually in Europe.
Zacks Rank & Key Picks
Investors looking for well-placed stocks in the health care sector can consider BioMarin Pharmaceutical Inc. (BMRN - Free Report) , Exelixis, Inc. (EXEL - Free Report) and Amarin Corporation plc (AMRN - Free Report) . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Amarin’s loss estimates have narrowed from 53 cents to 40 cents for 2016 and from 36 cents to 27 cents for 2017 over the last 60 days. The company’s share price has soared 58.2% year to date.
BioMarin’s loss estimates have narrowed from 28 cents to 25 cents for 2016 and from $1.16 to $1.11 for 2017 over the last 60 days.
Exelixis’ loss estimates have narrowed from 76 cents to 63 cents for 2016 and from 22 cents to 3 cents for 2017 over the last 60 days. The company has posted a positive earnings surprise twice in the four trailing quarters with an average beat of 9.1%. Its share price has skyrocketed 104.1% year to date.
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