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Pulmovant's Mosliciguat Gets Orphan Drug Status In Japan

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us

Pulmovant, a unit of Roivant Sciences Ltd. (ROIV), Thursday said its drug candidate mosliciguat for the treatment of Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD), has been granted orphan drug designation by Japan's Ministry of Health, Labour and Welfare (MHLW).

A Phase 2 study of mosliciguat in PH-ILD, dubbed PHocus is underway.

Orphan drug designation from MHLW provides key regulatory and development benefits, including priority consultation, reduced regulatory fees, and up to 10 years of market exclusivity following potential approval.

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