FDA, New Products

Watch out Merck: Heron snagged FDA approval on Emend competitor

San Diego’s Heron Therapeutics $HRTX has won FDA approval for Cinvanti to prevent nausea and vomiting for patients on chemo. The drug will directly compete with Merck’s Emend, as it has bioequivalence — potentially sans the side effects.

Physicians and patients may prefer Heron’s new drug over Emend, since it’s free of polysorbet 80, which is known for inducing allergic reactions, coughing up blood, irregular heartbeat and fainting.

Cinvanti is the second anti-nausea drug in Heron’s product portfolio, with Sustol approved last August for the same indication. The approval should beef up Heron’s revenue, which totaled $20.7 million by the end of Q3 this year.

Emend brought in $549 million for Merck last year.

Barry Quart, CEO of Heron Therapeutics

Barry Quart, CEO of Heron, said he expects to launch Cinvanti in January 2018.

“To obtain FDA approval for a second product in just over a year is a significant achievement for Heron, and we remain on-track with our third important product, HTX-011, which we expect to file for FDA review in 2018,” Quart said in a statement.

HTX-011 is in Phase III trials for the prevention of post-operative pain.


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