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Recent US FDA Breakthrough Therapy Designations, From Mass Market Vaccines To Rare Diseases

 
• By Bridget Silverman

Merck’s latest pneumococcal vaccine and Pfizer’s RSV vaccine notched new BTDs, along with Zambon’s inhaled antibiotic for non-CF bronchiectasis, Acer’s vascular Ehlers-Danlos syndrome drug and Dizal’s targeted lung cancer candidate.

FDA breakthrough sign
• Source: Nielsen Hobbs; the Pink Sheet | Getty, Shutterstock images

The US FDA’s most recent set of breakthrough therapy designations went to products that are already in advanced development – including one product that had already sought approval and received a complete response letter for the same condition.

Acer Therapeutics Inc.’s Edsivo (celiprolol) BTD in certain patients with vascular Ehlers-Danlos syndrome (vEDS) suggests a comeback of sorts after its new drug application received the complete response letter in June 2019

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