logo
  

U.K. Approves Rhythm Pharma's Imcivree For Treatment Of Obesity And Control Of Hunger

Rhythm Pharmaceuticals Inc. (RYTM) said that the Great Britain's Medicines & Healthcare Products Regulatory Agency or MHRA has granted marketing authorisation to Imcivree or setmelanotide for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 or PCSK1, deficiency or biallelic leptin receptor or LEPR deficiency in adults and children 6 years of age and above.

It is the first-ever authorised treatment option in Great Britain (England, Scotland and Wales) for these rare genetic diseases of obesity, the company said.

The National Institute for Health and Care Excellence or NICE is scheduled to review the dossier for Imcivree in December 2021. Guidance for coverage of Imcivree under the United Kingdom's National Health Service (NHS) is anticipated in the second quarter of 2022.

The company noted that the MHRA authorisation of Imcivree is based on results from the largest studies conducted to date in obesity due to POMC, PCSK1 or LEPR deficiency.

In two Phase 3 clinical trials, 8 of 10 patients with obesity due to POMC or PCSK1 deficiency achieved greater than 10 percent body weight loss after one year of treatment with IMCIVREE and 5 of 11 patients with obesity due to LEPR deficiency achieved greater than 10 percent body weight loss after one year of treatment with IMCIVREE.

Additionally, in both studies, significant decreases in body mass index (BMI) were demonstrated across patients who were 6 to 17 years old at baseline.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Asweets Global Inc. is recalling about 2,000 units of Wonder & Wise Activity Tables for potential risk of choking hazard to young children, a statement by the U.S. Consumer Product Safety Commission (CPSC) showed. The company said the screws of the tables can become loose and/or detach from the xylophone component of the activity tables to pose a choking hazard to young children. Chinese e-commerce giant Alibaba Group Holdings Ltd. (BABA) reported Thursday a net loss for the fourth quarter that sharply widened from last year, despite 9 percent growth in revenues, hurt by a decreases in the market prices of our equity investments in publicly-traded companies. Omni-channel fashion retailer Macy's, Inc. (M) reported Thursday a first-quarter net income of $286 million or $0.98 per share, sharply higher than $103 million or $0.32 per share in the prior-year quarter. Excluding items, adjusted net income for the quarter was $315 million or $1.08 per share, compared...
RELATED NEWS
Follow RTT