Less than a month after an FDA advisory committee voted 6-3 to reject AstraZeneca’s camizestrant, Europe’s Committee for Medicinal Products for Human Use (CHMP) has blessed it with a positive opinion.
The European experts have recommended that the oral SERD treatment can be used in combination with a CDK4/6 inhibitor for patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer if they have ESRI mutations.
Last month, the FDA’s Oncologic Drugs Advisory Committee (ODAC) raised questions about the design of the pivotal SERENA-6 study, which showed a 56% improvement in progression-free survival (PFS) for switching to camizestrant, used on top of a CDK4/6 inhibitor, compared with continuing treatment with an aromatase inhibitor (AI) and a CDK4/6 drug.
The FDA took issue with AZ’s study, arguing it did not address whether this first-line switch approach provides long-term benefit to patients compared with the standard practice of waiting until disease progression to use a new therapy. Although camizestrant extended median PFS by 6.8 months in the trial design, the FDA was unsure of its clinical meaningfulness.
The FDA has not yet issued its decision on the drug, though it usually sides with the recommendations provided by their expert committees. In Europe, the drug will carry the brand name Etcamah.
Europe signs off on Novo’s Wegovy pill
The CHMP also endorsed Novo Nordisk’s Wegovy pill, clearing it for approval to become the first oral GLP-1 treatment for obesity in Europe. The arrival of the Wegovy pill comes as other drugmakers are developing their investigational oral weight-loss treatments.
Last month, Eli Lilly gained approval in the United States for its obesity pill Foundayo. The Indianapolis company has yet to submit for approval of its pill in Europe. The FDA signed off on oral Wegovy in January and the company reported its first quarter sales at $355 million.
While injected Wegovy can be used by patients age 12 and older, the European recommendation for the oral version covers adults only. The daily pill must be taken on an empty stomach, after an eight hour fast, followed by 30 more minutes without food, drink or any other medications.
The nod was backed by a trial of 307 adults who were obese or overweight, with participants losing an average of 14% of their body weight compared to a 2% figure for those on placebo.
The CHMP also signed off on two versions of Novo-developed GLP-1 liraglutide, which are now sold by German generics specialist Stada. The positive opinions were issued for obesity treatment Ablymico, which is a hybrid version of Novo’s Saxenda, and for Liraglutide Stada, which contains the same active substance of Novo’s Victoza.
New drugs gain CHMP nods
The CHMP has put its stamp of approval on Boehringer Ingelheim’s Jascayd for two lung disorders—idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). The nod comes two months after Boehringer Chairman Shashank Deshpande expressed frustration over the regulatory timelines in Europe.
“Why is that possible in one jurisdiction or territory and why does it take six months, nine months in Europe?” Deshpande asked.
Jascayd is the first new treatment in more than a decade for IPF, a potentially fatal disorder that causes a buildup of scar tissue in the lungs and limits oxygen intake. As a selective phosphodiesterase-4B (PDE4B) inhibitor, Jascayd brings a new mechanism of action to the market. The FDA approved Jascayd for IPF in October of last year and two months later followed with an expansion to treat PPF.
Meanwhile, Novartis has scored a CHMP nod for Vijoice, an oral drug that treats the rare disorder PIK3CA-related overgrowth spectrum (PROS). The endorsement comes four years after the FDA approved the treatment, which is the first of its kind to address the underlying cause of the condition. The CHMP green light covers patients age 2 and older.
Additionally, a month after the FDA rejected a novel aesthetic product from AbbVie, the CHMP has signed off on it for glabellar frown lines following local muscular paralysis. The U.S. regulator gave the fast-acting follow-on to its blockbuster Botox a thumbs down because of a manufacturing snafu. The injected treatment works for two to three weeks, often giving patients confidence to move onto longer-acting Botox.
NICE does a 180 on Genmab’s Tivdak
Over in the United Kingdom, the National Institute for Health and Care Excellence (NICE) has reversed its opinion on Genmab’s cancer treatment Tivdak, now recommending (PDF) its use by the National Health Service (NHS) for those with recurrent or metastatic cervical cancer who have had disease progression despite earlier systemic therapy.
England’s Medicines and Healthcare Products Regulatory Agency (MHRA) approved Tivdak in the indication December of last year. But two months ago, in its initial guidance, NICE questioned its cost-effectiveness, saying it was “higher than the range normally considered acceptable.”
