After a surprising rejection in August, two pharma companies are working toward approval ahead of their Type A meeting with the FDA for a drug with significant potential
Medexus Pharmaceuticals Inc. (TSX: MDP) and medac GmbH announced that the U.S. Food and Drug Administration (FDA) has granted a Type A meeting to medac for treosulfan, a bifunctional alkylating agent developed for use as part of a conditioning treatment for patients prior to bone marrow transplants.
In August, medac, licensor for Medexus, received a non approval letter from the FDA for use of treosulfan in the United States. The FDA provided recommendations, which were covered by medac’s existing development plan for treosulfan. The drug was approved by Health Canada in June 2021, under the brand name Trecondyv.
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