Neurological

FDA is reviewing sNDA for purified cortrophin gel for multiple indications

Subjects ” multiple sclerosis

The Food and Drug Administration has accepted the re-submitted supplement application for a new drug for Purified Cortrophin® Gel (Repository Corticotropin Injection) for multiple indications on its previously approved label for review including, but not limited to, acute exacerbations of multiple sclerosis, rheumatoid arthritis and nephrotic syndrome.

Purified Cortrophin Gel is a purified adrenocorticotropic hormone. ANI Pharmaceuticals acquired Merck’s application for cortrophin gel in January 2016 and submitted the sub-application to the FDA in March 2020.

In April 2020, the company received a letter of denial from the FDA stating that certain parts of the Chemistry, Manufacturing, and Controls section of the application were not complete enough to allow for a substantive review. Since then, the company has dealt with the issues mentioned in the letter.

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The target date of the Act on Charges for Prescription Drugs (PDUFA) has been set for the application to be October 29, 2021.

Chris Mutz, ANI Pharmaceuticals’ Chief Commercial Officer and Head of Rare Disease, said, “The availability of a second corticotropin – or [adrenocorticotropic hormone]-based- treatment makes sense for patients struggling with the devastating consequences of chronic autoimmune diseases. “

References

  1. ANI Pharmaceuticals announces FDA approval of a complementary new drug containing Purified Cortrophin® Gel for multiple indications including multiple sclerosis, rheumatoid arthritis and nephrotic syndrome. Press release. ANI Pharmaceuticals, Inc. Accessed August 31, 2021. https://www.businesswire.com/news/home/20210831005322/en/ANI-Pharmaceuticals-Announces-FDA-Acceptance-of-Purified-Cortrophin%C2%AE- Gel -supplementary-new-drug-application-for-multiple-indications-including-multiple-sclerosis-rheumatoid-arthritis-and-nephrotic-syndrome.
  2. ANI receives a letter from the FDA rejecting the submission of Cortrophin® Gel. Press release. ANI Pharmaceuticals, Inc. Accessed August 31, 2021. https://www.prnewswire.com/news-releases/ani-receives-refusal-to-file-letter-from-fda-for-cortrophin-gel-301048877. html.

This article originally appeared on MPR

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multiple sclerosis

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