ANI Pharmaceuticals is asking the U.S. Food and Drug Administration (FDA) for the right to reintroduce in the U.S. market its Cortrophin Gel (repository corticotropin injection, 80 U/ml) to treat acute exacerbations in multiple sclerosis (MS) and other diseases.
The compound consists of an adrenocorticotropic hormone (ACTH) gel preparation. It works by enhancing the production of steroids, which help to reduce inflammation and more rapidly resolve MS relapses or flares.
Cortrophin Gel was approved by the FDA in 1954, when the market for repository corticotropin injections began booming and a half-dozen corticotropin therapies were in use, ANI reported in a press release.
If approval is given, the company said it plans to price its gel “at a substantial discount” to that of Acthar Gel, with the aim of reintroducing competition into the market for this treatment.
ANI reports that, on its previous label, the gel was approved to treat acute flares in 54 different conditions, from MS to rheumatoid arthritis, systemic lupus erythematosus and ulcerative colitis. But it fell out of use in the 1980s.
“Cortrophin Gel represents the last real hope for potential competition for H.P. Acthar Gel,” Arthur S. Przybyl, president and CEO of ANI, said in the release. “In the past, these two products competed with each other and were largely viewed as interchangeable.”
ANI acquired the rights for cortrophin gel from Merck in January 2016, and has since been working to validate the therapy’s active pharmaceutical ingredient and re-establish its manufacturing process, ensuring all meet current FDA standards.
“ANI’s effort to re-commercialize Cortrophin Gel has led to a high-quality product that is the result of a robust modernization plan,” Przybyl added.
The request to the FDA was filed as a prior approval supplement (PAS) for Cortrophin Gel. Comprehensive data characterizing the mode-of-action of the gel’s active ingredient was included in the application, the company reports.
“We are very pleased to have submitted this PAS on schedule and in hopes of bringing Cortrophin Gel back to the market for both patients and physicians,” said Mark Ginski, vice president of corticotropin development for ANI.
“Today’s submission marks a significant milestone for our company,” Przybyl added. “I am incredibly proud of what our Cortrophin Gel team has accomplished over the past 4 years. This drug is truly a transformational opportunity for ANI.”
Under FDA rules, the agency is expected to decide if ANI’s application is complete and ready for a potential approval review within four months. Whether extraordinary demands on the agency due to the coronavirus pandemic will delay this initial review is not known.
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