Ascendis crosses FDA finish line with once-weekly growth hormone—but Pfizer is hot on its trail

With its first approval in hand, Ascendis Pharma is gearing up for its stateside commercial debut. But despite touting an edge in convenience within its initial pediatric indication, the clock is ticking as a rival drug from Pfizer barrels toward the regulatory finish line.

The FDA on Wednesday gave a thumbs up to Ascendis' long-acting growth hormone lonapegsomatropin-tcgd. Now christened Skytrofa, the somatropin prodrug has been approved in kids ages one and older with growth hormone deficiency (GHD) who weigh at least 25.4 pounds. It’s also the first childhood GHD therapy that can be taken just once a week, Ascendis said in a release.