USFDA approves drug for Alopecia, includes safety warning too

Olumiant is a once-daily pill that will be sold in three different doses

185
USFDA Approval
USFDA Approval

Table of Contents

Last Updated on October 10, 2024 by The Health Master

The U.S. Food and Drug Administration (USFDA) cleared the first systemic therapy for severe alopecia areata, an autoimmune condition that causes hair loss, while warning patients of potentially deadly side effects.

Eli Lilly and Incyte developed the drug, known as Olumiant, which is already used to treat rheumatoid arthritis and certain patients with C-19.

It’s part of a class of medicines known as JAK inhibitors that have proven effective against a range of inflammatory diseases but have also been linked to conditions including heart attacks, strokes and cancer. 

Olumiant is a once-daily pill that will be sold in three different doses, Lilly said Monday.

The list price for a 30-day supply of the middle dose, 2 mg, will cost $2,497.20, but the actual cost to patients will depend on their insurance.

Safety warning

The caution in dosing goes along with a black box warning required by the FDA. Patients need to be advised of the potential for “serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis,” the agency said in announcing the approval of the medicine. 

 USFDA gives tentative nod to Alembic Pharma for Dasatinib tablets

USFDA gives final approval for Adapalene and Benzoyl Peroxide Topical Gel

USFDA gives approval for Leuprolide Acetate Injection

USFDA gives final nod to Zydus for Famotidine tablets

Indian Pharma Companies hiring former USFDA officers

USFDA withdraws approval for TG Therapeutics Cancer treatment

Phase I Clinical Trial Centres to be developed: ICMR

Topical steroid: Types, uses, side effects and treatment, revealed by doctors

Pharma Industry urges IPC regarding DT time of Soft Gelatin Capsules: Read

USFDA issues draft norms on Antibacterial therapies

Online sale of medicines will promote these issues related to Medicines

Allow private practice or 50% non-practice allowance: Doctors

Drug recall: Over 6 lakh bottles of Blood Pressure treatment tablets recalled

Drug alert: 41 out of 1233 samples declared as NSQ in May 2022

Side effects of painkillers: Matter sent to CDSCO

Latest Notifications regarding Pharmaceuticals

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news