CHMP gave positive opinions for Beovu and Recarbrio
Updated: 19 hours ago
Novartis’ Beovu (brolucizumab) received CHMP positive opinion for the treatment of wet age-related macular degeneration (AMD).
Nikos Tripodis, Worldwide Franchise Head, Novartis Ophthalmology “At Novartis, we remain committed to reimagining treatments for patients suffering from wet AMD, a leading cause of blindness worldwide.”
The approval is based on two head-to-head clinical trials HAWK and HARRIER clinical trials. The drug showed non-inferiority versus aflibercept, in both the trials, 30% if patients treated with Beovu gained at least 15 letters at year one.
Earlier, in October 2019, Beovu received approval from the U.S. Food and Drug Administration.
Merck’s Revarbrio (imipenem, cilastatin, and relebactam) received a positive opinion from CHMP for the treatment of infections due to aerobic Gram-negative organisms in adults.
“Merck remains focused on developing new antibacterial medicines that provide a meaningful benefit to patients fighting serious bacterial infections,” said Dr. Nicholas Kartsonis, senior vice president, infectious diseases and vaccines.
Earlier in July 2019, the drug received approval from the US FDA for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis and complicated intra-abdominal infections (cIAI).