Ofev receives orphan drug status for Potential Scleroderma

Ofev, a kinase inhibitor, has been declared as an orphan drug by European Commission and US Food and Drug Administration for the treatment of potential scleroderma and related interstitial lung diseases. The drug is currently in its phase 3 clinical trials.

The FDA and EMA’s designation of orphan status is granted to encourage new developments and therapies for rare diseases and disorders. Orphan Status can be applied to products proven safe and effective in treating conditions that affect a relatively small number of patients, and the designation may entitle up to seven years of US marketing exclusivity upon regulatory approval. Companies whose drugs have an orphan designation also receive certain tax credits and are exempted from paying prescription drug user fees normally required of companies submitting products for approval.

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