Global Anti-Epileptic Drugs for Pediatrics Market, by Drug Type (1st Generation, 2nd Generation, and 3rd Generation), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) is estimated to be US$ 918.9 million in 2019 and is expected to exhibit a CAGR of 7.5% over the forecast period (2019-2027).
Manufacturers are focusing on research and development activities and study about the effectiveness of generic drugs to find a solution to challenges associated with existing treatments of epilepsy in children. In 2017, a second trial conducted in the FDA-sponsored EQUIGEN project confirmed that a generic version of lamotrigine is bioequivalent to Lamictal, which is the brand-name form of the drug.
Furthermore, Sunovion submitted a supplemental New Drug Application (sNDA) to the U.S Food and Drug Administration (USFDA), to use Aptiom (eslicarbazepine acetate) as monotherapy or adjunctive therapy in the treatment of partial-onset seizures (POS) for children in the age group of 4 years and below. Pfizer, Inc. has molecules NCT02072824, NCT01463306, and NCT01747915 for epilepsy in their pipeline. In 2017, Epygenix Therapeutics, Inc. received the U.S. FDA approval for orphan drug designation to EPX-100 and EPX-200 that are indicated for the treatment of patients suffering from Dravet syndrome, which is a catastrophic form of epilepsy.
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The number of anti-epilepsy drugs has doubled over the last few decades and nine new drugs for treatment of pediatric epilepsy were launched in the last decade, as the benefits of the medicines are greater than the subsequent side-effects from the medicine. Third generation epilepsy drugs are rapidly replacing second and first generation drugs, as they are safer and more tolerable than the previous generation drugs. The newer drugs have better efficacy, with much better pharmacokinetic profiles and fewer drug interactions than the classic first generation drugs.
For instance, the third generation drugs, UCB’s Keppra (levetiracetam) and GlaxoSmithKline’s (GSK’s) Lamictal (lamotrigine) have rapidly become commonly used drugs for first-line treatments. The anticonvulsant medications are only FDA-approved for seizure disorders among children. Also, the currently available newer anti-seizure drugs have simple pharmacokinetics and more limited effects on liver metabolism, thus driving the anti-epileptic drugs for pediatrics market.
Key Takeaways of the Global Anti-epileptic Drugs for Pediatrics Market: