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Biotech Stocks Facing FDA Decision In October

Roche
Roche

On October 4, 2018, the FDA is scheduled to decide on Roche’s supplemental Biologics License Application for Hemlibra seeking approval for use in adults and children with haemophilia A without factor VIII inhibitors.

Hemlibra is already approved in the U.S. and EU for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with haemophilia A with factor VIII inhibitors.

Hemophilia is a rare but serious bleeding disorder. There are two main types - Hemophilia A, caused due to deficiency or dysfunction of clotting protein factor VIII, and Hemophilia B, caused due to deficiency or dysfunction of clotting protein factor IX. The current standard of care requires recurrent intravenous infusions of either plasma-derived or recombinant factor VIII or IX to control and prevent bleeding episodes.

But some people with hemophilia will develop inhibitors, making it difficult to treat. When a person develops an inhibitor, the body stops accepting the factor treatment product as a normal part of blood, thinking that thinks the factor is a foreign substance and tries to destroy it with an inhibitor.

Approved in the U.S. in November 2017, and in the EU in February of this year, Hemlibra raked in sales of 57 million Swiss francs ($58.2 million) in the first half of 2018.

RHHBY.OB closed Thursday’s trading at $30.31, down 0.75%.

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