Last Updated on December 31, 2023 by The Health Master
San Rafael: BioMarin Pharmaceutical Inc. has recently announced that the U.S. Food and Drug Administration (USFDA) has granted accelerated approval to VOXZOGO (vosoritide) for Injection, indicated to increase linear growth in pediatric patients with achondroplasia five years of age or older with open epiphyses (growth plates).
This indication is approved under accelerated approval based on an improvement in annualized growth velocity (AGV).
Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory studies.
To fulfill this post-marketing requirement, BioMarin intends to use the ongoing open-label extension studies compared to available natural history.
“Voxzogo is a medical first that is rooted in BioMarin’s focus on molecular genetics and targets the underlying cause of the condition.
More than a decade of scientific research underpins the medical advance that Voxzogo represents.
“We thank the USFDA for recognizing its value as the first therapeutic treatment option for children with achondroplasia,” said Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin.
Zydus Cadila gets USFDA nod to market generic Cancer drug in US
Aleor Derma gets USFDA nod for Antibacterial Cream: Alembic
USFDA gives nod to Zydus Pharma for Eluxadoline Tablets
USFDA gives final nod to Zydus Cadila for Glycopyrrolate Injection
USFDA approves Drug to treat Hyperactivity disorder
USFDA’s nod for Kerala’s local herb Manathakkali for Liver Cancer Treatment
Govt endorses these suggestions to amend D&C Act and DPCO
2 lakh Pharmacies in India by next year: Biddano
Drug recall: Sun Pharma recalls about 1.10 lakh bottles of Tadalafil…
UK calls for action on racial bias in Medical Devices
Long term benefits of Covaxin: Research
Lung cancer management in the era of precision medicine
CDSCO panel rejects Synokem Pharma’s application for oral Antidiabetic Drug
Eli Lilly files litigation against 20 Indian Pharma Companies
Latest Notifications regarding Pharmaceuticals
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:
