FDA Says No To TSRO, Ablynx On Track, MYL Leads In Herceptin Biosim Race In U.S.

(RTTNews) - Gilead Sciences Inc.'s (GILD) Vemlidy has been granted marketing authorization by the European Commission for the treatment of chronic hepatitis B virus infection in adults and adolescents.

Vemlidy becomes the first new treatment for chronic hepatitis B infection to be approved in the European Union in nearly a decade.

The drug was approved by the FDA on November 10, 2016 for the treatment of chronic HBV infection in adults with compensated liver disease, and by the Japanese Ministry of Health, Labour and Welfare on December 19, 2016 for the suppression of viral replication in chronic hepatitis B patients with evidence of hepatitis B virus replication and abnormal liver function.

In the U.S., Vemlidy's label sports a boxed warning about the risk of lactic acidosis and severe hepatomegaly with steatosis.

GILD closed Wednesday's trading at $73.77, down 1.65%.

Mylan N.V.'s (MYL) biologics license application for MYL-1401O, a biosimilar candidate to Roche Holding AG's (RHHBY.OB) breast cancer drug Herceptin has been accepted for review by the FDA, and a decision date has been set for September 3, 2017.

If approved, MYL-1401O will be the first biosimilar version of Herceptin in the U.S.

Mylan has a deal in place with Biocon Ltd. for a broad portfolio of biosimilar and insulin products. MYL-1401O is Mylan and Biocon's first U.S. regulatory submission through the 351(k) pathway.

MYL-1401O is also under review by the European Medicines Agency.

Biosimilar versions of Herceptin are available in India and Iran for the treatment of breast cancer, according to Research and Markets.

MYL closed Wednesday's trading at $37.28, down 4.29%.

The FDA has refused to approve TESARO Inc.'s (TSRO) intravenous formulation of Rolapitant, developed for the prevention of chemotherapy-induced nausea and vomiting.

While no concerns have been raised related to efficacy or safety profile, the regulatory agency has sought additional information regarding the in vitro method utilized to demonstrate comparability of Rolapitant IV produced at the two proposed commercial manufacturers of the drug product.

An oral formulation of Rolapitant was approved by the FDA under brand name Varubi on September 1st, 2015, and has been available in the U.S. since November 2015. Sales of Varubi totaled $4.41 million in the first nine months of 2016.

Tesaro obtained an exclusive, royalty bearing, sublicensable worldwide license, to research, develop, manufacture, market and sell Rolapitant from Opko Health Inc. (OPK) in December 2010.

TSRO closed Wednesday's trading at $145.90, down 0.91%.

Ablynx (ABYLY.OB) has dosed the first patient in its phase IIb study with ALX-0171 for the treatment of RSV infections.

Respiratory syncytial virus (RSV) is the most common cause of infections of the lower respiratory tract and is the world's primary viral cause of serious diseases of the lower respiratory tract in infants and young children.

Topline results from this study, dubbed Respire, are expected in the second half of 2018.

ABLYF.OB closed Wednesday's trading at $12.62, unchanged from the previous day's close.