Keeping Track: First-In-Class Candidates In COPD, Cancer Join US FDA Review Queue
Recent applications for approval also include another DMD therapy, another hemophilia B gene therapy, and a new antibiotic.
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The company reported positive results from its study in lower-risk myelodysplastic syndrome, where it forecasts a market potentially exceeding 30,000 in US and major European markets and generating up to $1.2bn in sales.
Pfizer’s fidanacogene elaparvovec has hit the mark in a Phase III hemophilia B trial just a month after rival UniQure’s Hemgenix won US approval, with Pfizer’s plans for regulatory action raising the stakes for Hemgenix.
After once again showing significant improvements in lung function and a 36% reduction in rate of exacerbations over 24 weeks, Verona is confident that its dual PDE3/4 inhibitor will change the treatment paradigm for COPD.