Pharma major Akums Drugs and Pharmaceuticals on June 27 said that it has received the Drug Controller General of India’s (DCGI) approval for Perampanel Oral Suspension for the treatment of seizures in patients above 12 years.
“The Perampanel Oral Suspension will be an adjunctive therapy for the treatment of partial-onset seizures (POS) with or without secondarily generalised seizures, as well as primary generalised tonic-clonic (PGTC) seizures in patients with epilepsy,” the company said in a statement.
The Perampanel Oral Suspension is a bioequivalent formulation to the US FDA-approved FYCOMPA (perampanel) Oral Suspension.
According to World Health Organisation (WHO), around 50 million people worldwide have epilepsy, making it one of the most common neurological diseases globally.
An estimated 5 million people are diagnosed with epilepsy every year. India has more than 10 million patients with epilepsy.
“We are excited about the approval of Perampanel Oral Suspension, as it provides another treatment option for patients with epilepsy who may have difficulty swallowing tablets or prefer liquids," said Sanjeev Jain, Joint Managing Director, Akums said.
Jain said the newly approved drug offered a new option for the treatment of partial-onset epilepsy.
“It holds the potential to play a key role in improving seizure management, particularly in poorly controlled adults and adolescents,” he added.
According to the company, Perampanel Oral Suspension formulation will be available in 100ml bottles, with a strength of 0.5mg/ml.
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