First Nasal Adrenaline Spray Among 10 Products Heading For EU-Wide Approval

The June meeting of the European Medicines Agency's human medicines committee brought mixed fortunes for companies. 10 new products were recommended for pan-EU approval, two drugs were rejected, while the conditional approval of one drug is set to be revoked. PTC Therapeutics again faced disappointment regarding its Duchenne muscular dystrophy drug Translarna, but has vowed to fight back.

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Opinions Adopted At CHMP’s June Meeting Present A Mixed Bag For Companies • Source: Shutterstock

ARS Pharmaceuticals' EURneffy (epinephrine) is on track to become the first needle-free adrenaline option for emergency treatment of allergic reactions in the EU, while MSD's orphan drug Winrevair (sotatercept) is set to become the region's first activin signaling inhibitor therapy for pulmonary arterial hypertension (PAH).

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