Amicus Pompe Disease Combo’s Approvability In Question As Key Trial Misses Mark
Company Touts ‘Totality Of Data’ As Supporting Approval
The company hopes to score a nod from the US FDA based on a secondary endpoint that won approval for Sanofi’s Lumizyme.
You may also be interested in...
While Amicus will transfer the gene therapy portfolio’s R&D risk to Caritas, it retains a financial interest in many of the spinout’s programs. Pompe candidate AT-GAA accepted for FDA review.
The European Medicines Agency decided this month whether to grant fast-track review for planned marketing authorization applications for three potential new orphan treatments.
The shingles vaccine’s move to health care practices, as well as inventory moves, contributed to its 41% sales growth during the quarter after a difficult year due to COVID-19.