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March 13, 2018

European approval sought for Melinta antibiotic

PHOTO | CONTRIBUTED Melinta's antibiotic Baxdela, which treats MRSA.

Melinta Therapeutics announced this week that its partner is seeking permission to sell the firm’s successful antibiotic delafloxacin in Europe.

The medication, used to treat severe skin infections, including MRSA (Methicillin-resistant Staphylococcus aureus), is already marketed in the United States under the name Baxdela. If approved by regulators, the drug would be branded Quofenix in Europe, the New Haven-based company said.

“This is an important milestone for Melinta and, if approved, would represent a significant expansion of delafloxacin’s market reach,” Melinta CEO Dan Wechsler said.

The Menarini Group, Melinta’s commercial and development partner, submitted the application to the European Medicines Agency, according to the company. The request is based on two studies that meet U.S. Food and Drug Administration and EMA approval criteria, the firm said.

Under a 2017 agreement, Menarini has exclusive rights to market delafloxacin in 68 countries in Europe and the Asia-Pacific region, including China, Russia, South Korea and Australia.

Delafloxacin treats Acute Bacterial Skin and Skin Structure Infections, also known as ABSSSI.

Christopher Hoffman can be reached at news@newhavenbiz.com

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