(Reuters) - The U.S. Food and Drug Administration on Monday approved Antares Pharma Inc's injectable drug to treat low testosterone levels in men, the company said, nearly a year after being rejected.
The drug, however, comes with a boxed warning - the FDA's strongest - flagging risks of a rise in blood pressure that can cause major cardiovascular events.
Shares of Antares were up 4.2 percent at $3.50 in premarket trading.
The FDA had declined to approve the drug, Xyosted, in October last year, highlighting elevated blood pressure, depression and suicidal tendencies in patients.
Prescriptions for low testosterone, or "Low T", have soared over the past decade, driven by a surge in use by aging men.
About 6.5 million retail prescriptions for testosterone replacement therapy were filled in 2017, the company said.
Xyosted's approval makes it the second branded injectable testosterone replacement therapy in the low-T market and could prove to be both a meaningful financial and sentiment catalyst, Raymond James analyst Elliot Wilbur said in a research note ahead of the FDA's nod.
This year, Antares won approval for its generic version of Mylan NV's EpiPen, snagged a broader label for its subcutaneous Makena injection and inked a development agreement with Pfizer Inc for a combination drug-device pen.
AbbVie Inc's AndroGel, one of the most widely used products that raked in sales of $577 million in 2017, accounts for roughly 60 percent of the total testosterone replacement therapy market, Wilbur said.
Xyosted has been approved in three dosage strengths - 50 mg, 75 mg and 100 mg - and is indicated for testosterone replacement therapy in adult males with a deficiency or absence of endogenous testosterone.
(Reporting by Aakash Jagadeesh Babu and Saumya Sibi Joseph in Bengaluru; Editing by Arun Koyyur and Maju Samuel)
