After struggling with bankruptcy, Melinta scores much-needed FDA approval

March 16, 2021

Nearly a year after emerging from bankruptcy proceedings that restructured the company’s ownership, antibiotics-maker Melinta Therapeutics has notched a new FDA approval.

This week, the company announced that Kimyrsa, its treatment for acute bacterial skin and skin structure infections, has been given the green light by the agency. According to the company, the type of skin infections targeted by Kimyrsa impact about 14 million patients in the U.S. each year and are the 8th most common reason for ER visits.

Kimyrsa is a next-gen version of the company’s Orbactiv, but comes with a new benefit — it only has to be administered once, compared to the standard multidose treatment options.

Co-founded by a Nobel Prize-winning Yale scientist in 2000, Melinta’s journey has demonstrated the difficulties faced by antibiotics makers. Despite having several approved treatments on the market, the company ran into financial trouble as more doctors have become reluctant to prescribe antibiotics unless they are absolutely necessary. In 2018, the company ultimately disbanded its R&D team and then filed for bankruptcy in 2019.

Melinta was ultimately bought out by Deerfield Management to settle a $140 million loan to the company. 

Melinta is now hoping that the single-dose, long-acting formulation of Kimyrsa will give it an edge over competitors in the market.

Read the press release.