Ascendis Will Take On Daily Genotropin With Weekly Skytrofa
Company Will Try To Assert Superiority Claim
Ascendis’s growth hormone deficiency drug Skytrofa will offer a convenience advantage as a weekly injectable. But the label does not clearly delineate superiority shown in a Phase III trial.
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The firm plans to submit to the US FDA in the third quarter and with the European Medicines Agency in the fourth quarter based on positive Phase III study results.
The European Medicines Agency had a busy time at its meeting last week. It gave the green light to 11 products, four of which are for rare diseases including ANCA-associated vasculitis, and to a range of treatments for conditions as diverse as non-small cell lung cancer, smallpox, migraine, COPD, COVID-19 and obesity.
The US FDA has extended the user fee date by three months for the partners’ BCMA-targeting CAR-T therapy but its first-to-market rival is facing manufacturing challenges that limit access to treatment.