2023-03-31 11:11:44 ET
- A panel of the European Medicines Agency (EMA) said that Viatris ( NASDAQ: VTRS ) withdrew an application for a generic HIV therapy Raltegravir Viatris on Feb. 22.
- Raltegravir Viatris was developed as an antiviral drug to treat human immunodeficiency virus type 1 (HIV-1) infection in adults and children (weighing at least 40 kg).
- The EMA's Committee for Medicinal Products for Human Use (CHMP) said that based on review of data and the company's response to the agency's questions, at the time of the withdrawal, the regulator had some concerns.
- The EMA considered that bioequivalence with the reference drug was not shown as the study results showed differences in the absorption rate.
- The agency was also concerned about the data provided on the quality of the therapy which could not guarantee that future batches of Raltegravir Viatris would be of adequate quality.
- The CHMP noted that the therapy could not authorized based on the data from the company.
- Viatris informed the agency that it withdrew its application as the EMA considered the data provided did not show bioequivalence of the product.
For further details see:
Viatris pulls generic HIV drug filing in EU on bioequivalence woes