SAN MATEO, Calif., Sept. 21, 2022 /PRNewswire/ -- Biocodex, Inc., a pharmaceutical company and manufacturer of DIACOMIT® (stiripentol), announced today that the U.S. Food and Drug Administration (FDA) has approved DIACOMIT for the treatment of seizures associated with Dravet syndrome in patients 6 months and older, weighing 15 lb or more, and taking clobazam.1 The antiseizure treatment first received FDA approval in 2018 for children 2 years and older.
PANTHERx Rare announces that it has been selected by Biocodex as their new exclusive U.S. pharmacy distribution partner for DIACOMIT® (stiripentol)....
MEXICO CITY, Sept. 14, 2021 /PRNewswire/ -- m8 Pharmaceuticals and Biocodex have signed an exclusive licensing agreement for the Mexican and Brazilian market for Diacomit® (stiripentol). Diacomit® is approved for adjunctive treatment with clobazam and valproate in Dravet syndrome in over 27 countries, including North America and Europe. Dravet syndrome, also known as severe myoclonic epilepsy in infancy (SMEI), is a catastrophic early onset epileptic syndrome that is thought to affect approximately 1,000 to 2,000 patients in Mexico, and approximately 2,000 to 4,000 patients in Brazil. In most cases, the first seizures occur during the first year of life. Dravet syndrome is characterized by severe epilepsy, psychomotor retardation, and often ataxia. Status epilepticus is frequent and is thought to be in part responsible for the high premature mortality rate reported in these patients, ranging from 15.9 to 18%.
In April, the U.S. Food and Drug Administration (FDA) issued a Refuse to File (RTF) letter to Zogenix for its New Drug Application (NDA) for Fintepla (fenfluramine hydrochloride). The drug was developed to treat seizures associated with Dravet syndrome, a rare form of epilepsy characterized by frequent and prolonged seizures.
Encoded Therapeutics reeled in $104 million in series C cash to bankroll the development of its lead program: a precision gene therapy for Dravet syndrome, a rare form of epilepsy. The Bay Area biotech will also use the funds to push its preclinical programs and come up with new treatments for severe genetic disorders.
Let’s have a look at the recent new drug approvals. 2018 was quite a year, by the numbers. C&E News has a comprehensive roundup: 59 approvals (versus 46 in 2017, which was already a record by itself), and about two-thirds of those small molecules. There are some very interesting molecules in the list, and I always recommend that medicinal chemists sit down every so often and look over the structures of approved drugs as if you’re seeing them for the first time (say, as screening hits). You might be surprised at how many of them you find chemically somewhat unappealing – would you aim for an n-hexyl ether in your final structure (Mulpleta/lusutrombopag), the heterocyclic ring in the lower section of Xofluza (baloxivir marboxil), or think that 3,4-diaminopyridine (Firdapse) or Diacomet (stiripentol) could be drugs at all?
GENTILLY, France, Aug. 23, 2018 /PRNewswire/ -- BIOCODEX SAS is pleased to announce that on August 20th, 2018, the Food and Drug Administration (FDA) has approved DIACOMIT (stiripentol) for the treatment of seizures associated with Dravet syndrome (DS) in patients 2 years of age and older taking clobazam. DIACOMIT is expected to be available in U.S. pharmacies in early January 2019.
The Scottish Medicines Consortium (SMC) has today published advice accepting four new medicines for use by NHS Scotland.