U.S. FDA approves adjunctive therapy & intravenous use of VIMPAT®
Category: #health  By Saipriya Iyer  Date: 2020-11-19
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U.S. FDA approves adjunctive therapy & intravenous use of VIMPAT®

UCB, a biopharmaceutical company, has recently gained the approval of the U.S. FDA (Food & Drug Administration) for its prescription medicine, VIMPAT®.

VIMPAT® (lacosamide) CV will now be used as an adjunctive therapy for the treatment of PGTCS (primary generalized tonic-clonic seizures). In addition, VIMPAT® injection has been approved for intravenous use among children of 4 years and above. PGTCS is a form of seizure over the brain that affects both sides, resulting in muscle stiffness and convulsions for up to a few minutes.

As per the statement made by UCB’s Head of U.S. Neurology, Mike Davis, the recent FDA approval highlights the commitment of the company to ensure the delivery of efficient treatment for people with epilepsy, as well as its strong focus on meeting the unmet needs of this disorder. The company has shown excitement towards the availability of VIMPAT® as a treatment option for patients with primary generalized tonic-clonic seizures.

The PGTCS approval is based on the clinical results of a Phase 3 trial published recently in the ‘Journal of Neurology, Neurosurgery & Psychiatry’. The adjunctive treatment using VIMPAT® demonstrated lower risks of developing a 2nd PGTCS during the treatment period of 24 weeks, with the corresponding reduction of risks by 45% (p=0.001).

As per the Phase 3 clinical results, VIMPAT® can be tolerated among patients with IGE (Idiopathic Generalized Epilepsy) and PGTCS. The common adverse reactions were nausea (10%), headache (14%), somnolence (17%), and dizziness (23%). VIMPAT oral solution and tablets were also approved to treat partial-onset seizures among children and adults, as the monotherapy & adjunctive therapy. Moreover, its injection was recently approved for treating partial-onset seizures in patients of 17 years and above.

Moreover, in October 2020, the CHMP (Committee for Medicinal Products for Human Use) of the EMA (European Medicines Agency) issued an opinion about the use of VIMPAT® as an adjunctive therapy to treat PGTCS. UCB is anticipating the regulatory reviews for the treatment using VIMPAT®  in Australia and Japan.

Source credit:

https://www.prnewswire.com/news-releases/ucbs-vimpat-lacosamide-cv-now-approved-by-fda-for-primary-generalized-tonic-clonic-seizures-and-expanded-pediatric-use-for-people-living-with-epilepsy-301174421.html



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Saipriya Iyer

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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

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