Pyros Receives FDA Nod For Infantile Spasm Treatment

The US Food and Drug Administration (FDA) has approved a new ready-to-use version of vigabatrin created by Pryos Pharmaceuticals for treating infantile spasms. This marks the first approval of a new drug formulation for this condition in 15 years. Pryos, based in the US, has developed an oral solution of vigabatrin called Vigafyde, specifically for children aged one month to two years with infantile spasms, when the benefits outweigh the risks of potential vision loss. This milestone was announced in a press release on June 17th.

Infantile spasms, an uncommon epilepsy type, are managed in the US using Sabril (vigabatrin), produced by Lundbeck Pharmaceuticals and approved by the FDA in 2009. Lundbeck obtained commercial rights from Sanofi for this medication. Sabril is offered in tablet form (500mg) and as a powder for oral solution (500mg), according to its drug label.

Vigabatrin presently features an FDA Risk Evaluation and Mitigation Strategy (REMS) due to its documented potential for causing irreversible vision impairment. Individuals eligible for Vigafyde must participate in the Vigabatrin REMS. Pryos plans to introduce Vigafyde along with the REMS program in the second half of 2024. Additionally, the company provides a dedicated support team to help families throughout their treatment experience.