Parsippany, New Jersey. Edenbridge Pharmaceuticals announces Yargesa (100mg miglustat capsules) receives CHMP Positive Opinion. Final approval will be first European Union-wide generic of Actelion’s Zavesca®* through the centralized procedure.
Edenbridge Pharmaceuticals, LLC announces that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Yargesa (100mg miglustat capsules). The total market for miglustat capsules in the EU is estimated to be €50 million and Edenbridge is exploring partnering, licensing and divestiture opportunities.
About Yargesa. Yargesa is a generic version of Actelion Registration Ltd’s Zavesca®* (100mg miglustat capsules) and is intended for treatment of adult patients with mild to moderate type 1 Gaucher disease. Bioequivalence of Yargesa was demonstrated through an in-vivo bioequivalence study against the reference product Zavesca®* currently marketed in the EU. The Marketing Authorisation application was submitted to the EMA by JensonR+ Limited as applicant on behalf of Edenbridge and the final decision from the European Commission is expected within a few months. When approved, Yargesa will be the first generic version of Zavesca®* approved through the centralized procedure for sale in all EMA member states.
About the CHMP. The CHMP is the scientific committee of the European Medicines Agency (EMA) and recommends medicines for Marketing Authorization across the member states of the European Union.
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“We are proud to have developed and achieved the first generic alternative to Zavesca®* through the centralized procedure to address this growing need in all EMA member states” notes Patrick Chu, President of Edenbridge Pharmaceuticals.