Pyros wins FDA approval for ready-to-use infantile spasm treatment

2024-06-18

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来源: Pharmaceutical Technology

Infantile spasms is a rare form of epilepsy. Credit: Shutterstock/FAMILY STOCK.

The US Food and Drug Administration (FDA) has signed off on a ready-to-use formulation of vigabatrin developed by Pryos Pharmaceuticals for infantile spasms, marking the first approval for a novel drug formulation in this space in 15 years.

US-based Pyros has developed a ready-to-use oral solution of vigabatrin, named Vigafyde. The drug is indicated for paediatric patients with infantile spasms aged one month to two years where the potential benefits outweigh the potential risk of vision loss, according to a 17 June press release.

Infantile spasms, a rare form of epilepsy, is currently treated in the US with Lundbeck Pharmaceuticals’ Sabril (vigabatrin) and its generic versions, the former being approved by the FDA in 2009. Lundbeck gained US commercialisation rights to the drug from Sanofi. Sabril is available as 500mg tablets and 500mg powder for oral solution, as per its drug label.

Vigabatrin currently has an FDA Risk Evaluation and Mitigation Strategy (REMS) Programme due to the drug’s known risk of causing permanent vision loss. Those eligible to take Vigafyde must be enrolled in the Vigabatrin REMS.

Pryos will roll Vigafyde out with the REMS programme in H2 2024. The company also has a personalised support team on hand to assist families through the treatment journey.

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Pyros wins FDA approval for ready-to-use infantile spasm treatment

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Vigafyde will join Pyros’ other vigabatrin drug Vigpoder, an oral solution, which is therapeutically equivalent to Sabril, and was approved by the FDA in 2022.

Infantile spasms usually begin in children aged one year or less and can lead to long-term neurological conditions such as continued seizures, other forms of epilepsy and autism spectrum disorder.

Vigafyde works by inhibiting GABA transaminase. This increases GABA levels in the brain and helps modulate neuronal excitability, giving better seizure control.

Sabril saw peak US sales of $229m in 2017 but after several market exclusivities expired, sales slumped. It is estimated to generate just $12m in annual sales by 2030, according to GlobalData’s Pharma Intelligence Centre.

GlobalData is the parent company of Pharmaceutical Technology.

Pyros’ 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.”

Pyros also has two other drugs in its pipeline, PYR-001 and PYR-002, with undisclosed therapeutic targets. PYR-001 is in late-stage clinical trials whilst PYR-002 is still in the early stages of development.

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