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Bristol-Myers' Daklinza-Sovaldi Label Expanded in the EU

Bristol-Myers Squibb Company BMY announced that the European Commission has expanded the use of Daklinza, in combination with Gilead Sciences Inc.’s GILD Sovaldi (sofosbuvir), to include three new patient populations for the treatment of chronic hepatitis C (HCV).

The approval allows the Daklinza-Sovaldi combination to be used with or without ribavirin, depending on the indication and HCV genotype, to treat HCV patients with decompensated cirrhosis, HIV-1 (human immunodeficiency virus) coinfection, and post-liver transplant recurrence of HCV.

We note that in Aug 2014, Daklinza was approved in the EU in combination with Sovaldi for the treatment of genotype 3 HCV patients without cirrhosis. Daklinza was also approved in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of adults with chronic HCV infection.

In Jul 2014, the Daklinza-Sovaldi combination was approved in the U.S. for the treatment of patients with chronic hepatitis C virus (HCV) genotype 3 infection.

In a separate press release, the company announced that it has stopped a phase III study which was evaluating Opdivo versus investigator’s choice in recurrent or metastatic platinum-refractory squamous cell carcinoma of the head and neck.

The study was stopped early after the independent Data Monitoring Committee stated that the study had already met its primary endpoint. An assessment conducted by the committee demonstrated superiority in overall survival, in patients who received Opdivo as compared to the control arm.

We note that Opdivo is approved as monotherapy for the treatment of BRAF V600 wild-type unresectable or metastatic melanoma, and BRAF V600 mutation-positive unresectable or metastatic melanoma.

Opdivo is also indicated for the treatment of patients with metastatic non-small cell lung cancer with progression on or after platinum-based chemotherapy, and advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy.

Bristol-Myers currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Celgene Corp. CELG and Ligand Pharmaceuticals Inc. LGND, both sporting a Zacks Rank #1 (Strong Buy).

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BRISTOL-MYERS (BMY): Free Stock Analysis Report
 
GILEAD SCIENCES (GILD): Free Stock Analysis Report
 
CELGENE CORP (CELG): Free Stock Analysis Report
 
LIGAND PHARMA-B (LGND): Free Stock Analysis Report
 
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