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Biotech Stocks Facing FDA Decision In August

Shionogi
Shionogi

Shionogi & Co. Ltd.’s (SGIOF.OB) New Drug Application for Lusutrombopag (S-888711) is under priority review by the FDA, with a decision date set for August 26, 2018.

The Company is seeking approval of Lusutrombopag for the treatment of thrombocytopenia in patients with chronic liver disease who are at increased risk for bleeding associated with invasive procedures.

In Japan, Lusutrombopag was approved in September 2015 for the improvement of thrombocytopenia associated with chronic liver disease in patients undergoing an elective invasive procedure.

There is one FDA-approved treatment for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure, and it is Dova Pharmaceuticals Inc.’s (DOVA) Doptelet. This drug was approved by the FDA as recently as May 21, 2018.

Doptelet was launched in the U.S. on May 31, 2018, and its Wholesale Acquisition Cost (WAC) is $9,000 for the 40mg daily dose and $13,500 for the 60mg daily dose.

SGIOF.OB closed Wednesday’s (Jul 25) trading at $52.51, unchanged from the previous day’s close.