Last Updated on December 31, 2023 by The Health Master
Bristol Myers Squibb said on Thursday the U.S. Food and Drug Administration (USFDA) approved its oral heart disease drug Mavacamten, making it the first cardiac myosin inhibitor to be permitted for use in the country.
Mavacamten, which Bristol Myers acquired in its $13 billion buyout of MyoKardia in 2020, will be used in the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy.
Hypertrophic cardiomyopathy is an inherited condition characterized by the thickening of the heart muscles, which is a common cause of sudden cardiac arrest in young people.
About one in every 500 people in the United States suffers from hypertrophic cardiomyopathy, according to the American Heart Association, with a large portion having obstructive hypertrophic cardiomyopathy.
The wholesale acquisition cost (WAC) per capsule price of Mavacamten is about $245.20. The monthly list price is $7,356.16, while the annual one is $89,500, Bristol Myers told Reuters in an emailed statement.
The company said the drug comes with a boxed warning for the risk of heart failure. Mavacamten reduces left ventricular ejection fraction and can cause heart failure due to systolic dysfunction.
A boxed warning on the label is FDA’s strictest warning and calls attention to serious or life-threatening risks of a drug.
USFDA gives tentative nod to Alembic Pharma for Ivabradine tablets
USFDA gives nod to Lupin for Desvenlafaxine ER tablets
USFDA authorises first C-19 diagnostic test using breath samples
USFDA gives approval to Aleor for Lidocaine & Prilocaine cream
USFDA gives nod to Indoco Remedies for Lacosamide injection
USFDA gives tentative approval to Alembic for generic Pradaxa capsules
Drug alert: 48 out of 1454 samples declared as NSQ in March 2022
Haryana ideal destination for Pharma Hub: Chief Secretary
Govt announces Indian Pharma and Medical Devices Awards 2022
High Court issues notice to DCGI related to approval of drugs with identical brand names
Drug recall: Quinapril HCl recalled due to N-Nitroso-Quinapril Content
DCGI approves these 3 C-19 vaccines for kids aged above five years
Customs Department starts issuing notices to Pharma Exporters
Govt approves 16 applications under PLI schemes for APIs & Medical Devices
NPPA fixes retail price of 302 new drugs in fiscal year 2021-22
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:
