Last Updated on October 17, 2024 by The Health Master
TG Therapeutics said that the US health regulator had approved its monoclonal antibody for treating patients with relapsing forms of multiple sclerosis, sending its shares up 47 percent in afternoon trade.
The approval by the US Food and Drug Administration (USFDA) widens the number of such drugs available for treating the disorder to three and may help soften the blow to the company’s finances from the withdrawal of its lymphatic cancer drug earlier this year.
TG Therapeutics said it was expecting to launch the drug, branded as Briumvi, in the first quarter of 2023, but did not give details on its pricing.
Chris Howerton, an analyst, Jefferies, said ahead of the approval that he was expecting the drug to be priced in the range of $30,000 per patient per year.
In comparison, Roche’s Ocrevus has a current list price of about $68,000 annually.
Unlike other MS drugs that target T cells, Briumvi belongs to a class of drugs that tackles B cells’ role in driving the inflammation that is central to the neurological disease.
The approval, which comes with a warning of infusion reactions from the drug, was based on a late-stage study that showed the drug was effective in reducing annualized relapse rates in patients.
USFDA gives final approval to this breast cancer injection
USFDA gives approval for Fulvestrant injection
USFDA gives approval for this Genetic Disorder drug
USFDA gives approval for Lymphoma Therapy
USFDA gives approval for Pregabalin capsules
USFDA gives approval for Brivaracetam Tablets
CDSCO orders audits of Pharma Manufacturers & Importers for Pharmacovigilance system
IPC launches 10 new impurities standards
USFDA gives final approval to this breast cancer injection
NPPA releases draft calculation sheet for ceiling price revision of 35 formulations
CDSCO and States starts joint inspections of Drug Manufacturing Units
DCGI calls for registering (MDTLs) Medical Devices Testing Laboratories
Confession in criminal proceedings: Ground for conviction ?
Registration for sale of Medical Devices: Procedure and conditions
Bulk transfer of Blood and Blood Components: Procedure and Conditions
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
