A year after Novo Nordisk surrendered its pursuit of an approval in the U.S. for IcoSema as a treatment for Type 2 diabetes, the Danish company has scored a recommendation for the combination drug in Europe.
The Committee for Medicinal Products for Human Use (CHMP) has given a thumbs-up to once-weekly Kyinsu, as it is known in Europe, to treat patients with Type 2 diabetes who can’t get sufficient control of their blood sugar with basal insulin or glucagon-like peptide 1 (GLP-1) receptor agonists.
Kyinsu combines once-weekly insulin Awiqli (icodec) with GLP-1 Type 2 diabetes treatment Ozempic (semaglutide).
In July of last year, the FDA rejected icodec as a treatment for Type 1 and Type 2 diabetes, citing its “manufacturing process.” The U.S. regulator also was swayed by a panel of experts who voted 7-4 against recommending it for approval in its Type 1 diabetes indication because of concerns about its potential to trigger episodes of low blood sugar.
The FDA’s complete response letter came three months after the European Medicines Agency (EMA) granted marketing authorization to Awiqli as a treatment for Type 1 and Type 2 diabetes, following a positive opinion from CHMP.
Drug endorsements for Bayer, Merck and more
The CHMP also recommended Bayer’s Lynkuet (elinzanetant) for approval to treat moderate-to-severe hot flashes or night sweats that accompany menopause.
In July, the UK and Canada approved the dual-action neurokinin, which targets the NK-3 and NK-1 receptors. The FDA also was expected to sign off on Lynkuet in July, but the regulator pushed the decision date forward by three months to Oct. 26.
With nods in the U.S. and Europe, Bayer would join Astellas as the second company with a hormone-free treatment for patients with moderate to severe hot flashes. Veozah was the first neurokinin 3 (NK-3) receptor antagonist approved in the indication and has drawn a peak sales potential projection of $3.6 billion from the company.
The CHMP also issued a positive opinion on Merck’s monoclonal antibody Enflonsia to prevent lower respiratory tract disease associated with respiratory syncytial virus (RSV). The shot, which is for infants, was approved by the FDA in June and enters the market as a challenger to AstraZeneca and GSK’s blockbuster Beyfortus.
Also making the grade with the CHMP experts was Johnson & Johnson’s Imaavy as a treatment for generalized myasthenia gravis (gMG). The European recommendation comes five months after the FDA endorsed Imaavy in the same indication.
After a re-examination, the CHMP has recommended granting marketing authorization for Cosmo Pharmaceuticals’ topical acne treatment Winlevi. The nod comes five months after the committee gave it a thumbs-down.
Label expansions
The CHMP has endorsed Amgen’s Uplizna as a treatment for immunoglobulin G4-related disease (IgG4-RD), a chronic inflammatory condition that can present in multiple organs and cause fibrosis and permanent organ damage, with or without symptoms. The FDA signed off on Uplizna for the disorder in April, five years after the drug hit the market as a treatment for neuromyelitis optica spectrum disorder (NMOSD).
Collecting two positive opinions from the CHMP was Merck’s cancer powerhouse Keytruda. One of the nods is to recommend approval of a subcutaneous route of administration for Keytruda and its associated formulation tweak. The recommendation applies to all approved adult indications in Europe. The FDA is expected to decide on the SC version of Keytruda next week.
The other thumbs-up is for Keytruda as a treatment for locally advanced head and neck squamous cell carcinoma and comes three months after the FDA signed off on the PD-1 inhibitor in the indication.
The CHMP has given a nod to Regeneron and Sanofi’s Dupixent as a treatment for the hives condition, chronic spontaneous urticaria (CSU). The FDA approved Dupixent in the indication in April of this year, making it the first new medicine for CSU in more than a decade.
Hipra Human Health has secured a CHMP recommendation for Bimervax as a booster to prevent COVID-19 in those 12 and older who have previously received an mRNA COVID-19 shot. The EU originally approved the booster in 2023 for those aged 16 and older.
Also making the grade with CHMP were AstraZeneca and Amgen's Tezspire as a treatment for chronic rhinosinusitis with nasal polyps. AZ's Koselugo got a thumbs-up for symptomatic, inoperable plexiform neurofibromas in adult and pediatric patients with neurofibromatosis type 1 aged 3 years and older.