Insmed’s recombinant drug receives orphan drug status

This orphan drug designation for Iplex grants Insmed seven years of market exclusivity upon approval for the myotonic muscular dystrophy (MMD) indication. In addition, Insmed is eligible for tax credits relative to its development costs, as well as assistance from the FDA in advancing the drug candidate through the regulatory process.

Insmed is currently conducting a 24-week Phase III enabling trial for Iplex in MMD, and recently was awarded a grant of approximately $2.1 million from the Muscular Dystrophy Association (MDA), which is expected to cover a substantial portion of the external costs associated with the trial.

Geoffrey Allan, president and CEO of Insmed, said: “Orphan status, combined with the recent $2.1 million MDA grant, positions us well to continue advancing this important product candidate through clinical development, and maximize the market opportunities for MMD available to us.”