US-based drugmaker Pyros Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for its ready-to-use vigabatrin oral solution Vigafyde.

Vigafyde (vigabatrin) is a medication designed to inhibit the enzyme GABA transaminase to increase the levels of gamma-aminobutyric acid (GABA) in the brain.

The drug is indicated for the treatment of paediatric patients aged one month to two years with infantile spasms, where the benefits outweigh the risk of vision loss.

Its impact is expected to extend beyond seizure management, with emerging research indicating potential benefits in mitigating neurodevelopmental complications.

Pyros is planning to commercially launch Vigafyde in the second half of 2024.

Pyros co-founder and CEO Michael Smith said: “The approval of Vigafyde marks the first new drug indicated for infantile spasms in fifteen years and underscores our unwavering commitment to supporting families facing this challenging condition.”

Pyros co-founder and chief operating officer Edwin Urrutia said: “This is a momentous day for patients and caregivers who have long awaited the first ready-to-use vigabatrin.

“I believe this approval will bring renewed energy and momentum to the infantile spasms community, enhancing our efforts to improve disease education, develop care pathways, and expand investment in infantile spasms research.”

Pyros has launched a personalised comprehensive support program, dubbed Pyros Total Care, to help families throughout the treatment journey.

Under the Pyros Total Care program, the company will provide personalised support to caregivers and those prescribed Vigafyde.

The program offers personal assistance and financial resources to caregivers, in line with the company’s commitment to prioritising patient access.