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Roche’s Lucentis Prefilled Syringe Approved in the U.S.


Roche Holding AG RHHBY announced that its ophthalmology drug Lucentis (0.5 mg) prefilled syringe (PFS) was approved in the U.S. as a new method of administering the drug for the treatment of patients with wet age-related macular degeneration (AMD) and macular edema after retinal vein occlusion (RVO).

The product will be available in the U.S. early next year.

Note that Lucentis is currently approved in the U.S. for wet AMD, macular oedema after RVO, diabetic macular edema (DME), and diabetic retinopathy (DR) in DME patients.

We remind investors that Roche has a collaboration agreement with Novartis AG NVS for Lucentis. While Roche holds the commercial rights for Lucentis in the U.S., Novartis holds the rights to commercialize the drug in ex-U.S. countries.



In a separate press release, Roche announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion for Venclyxto for the treatment of people with chronic lymphocytic leukemia (CLL) in the presence of 17p deletion or TP53 mutation who are unsuitable for or have failed a B-cell receptor pathway inhibitor.

A final decision from the European Commission is expected in the coming months.

Note that Venclyxto, marketed as Venclexta in the U.S., was approved in Apr 2016 for the treatment of patients with CLL with 17p deletion, who have received at least one prior therapy. The company also has a collaboration agreement with AbbVie Inc. ABBV for Venclyxto/Venclexta.

According to information provided by Roche, leukemia affects 350,000 individuals in the world. Around one-third of all newly diagnosed leukemia patients are estimated to be suffering from CLL.

Roche currently carries a Zacks Rank #5 (Strong Sell).

A Stock to Consider

Geron Corporation GERN is a better-ranked stock in the health care sector, sporting a Zacks Rank #1 (Strong Buy). The company has posted a positive earnings surprise twice in last four quarters, bringing the average beat to 20.78%. You can see the complete list of today’s Zacks #1 Rank stocks here.

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