Less than a month after the FDA’s advisory committee voted 6-3 to reject AstraZeneca’s Camistant, Europe’s Committee for Medicinal Products for Human Use (CHMP) celebrated by issuing a positive opinion.
European experts recommend that oral SERD therapy can be combined with CDK4/6 inhibitors in patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer with ESRI mutations.
Last month, the FDA’s Oncology Drugs Advisory Committee (ODAC) raised questions about the design of the pivotal SERENA-6 trial, which showed a 56% improvement in progression-free survival (PFS) when switching to a CDK4/6 inhibitor plus Camizetlant compared to continuing treatment with an aromatase inhibitor (AI) and a CDK4/6 drug.
The FDA objected to AZ’s study, arguing that it did not address whether this first-line approach provides long-term benefits for patients compared to the standard treatment of waiting until disease progression and using new treatments. Although camizestrant increased median PFS by 6.8 months in the study design, the FDA was unsure of its clinical significance.
The FDA has not yet issued a decision on the drug, but it typically supports recommendations provided by expert panels. In Europe, the drug is sold under the brand name Etcamah.
Europe signs Novo’s Wegovy tablets
The CHMP also supported Novo Nordisk’s Wigovy tablet, granting approval to become Europe’s first oral GLP-1 treatment for obesity. The introduction of Wegovy pills comes as other drug companies are developing investigational oral weight loss treatments.
Last month, Eli Lilly received approval in the United States for its obesity treatment drug Foundayo. The Indianapolis-based company has not yet applied for approval of the pill in Europe. The FDA approved Wegovy’s oral presentation in January, and the company reported first-quarter sales of $355 million.
The injectable form of Wegovy can be used by patients over 12 years of age, but in Europe the recommendation for the oral form is only for adults. Daily tablets should be taken on an empty stomach after 8 hours of fasting and without food, drink, or other medications for an additional 30 minutes.
This nod is backed up by a study of 307 obese or overweight adults, in which participants lost an average of 14% of their weight, compared to 2% for those who took a placebo.
The CHMP also approved two versions of the GLP-1 liraglutide developed by Novo and now marketed by German generic drug specialist Stada. Positive reviews were given to the obesity drug Abrimico, a hybrid version of Novo’s Saxenda, and liraglutide Stada, which contains the same active ingredient as Novo’s Victoza.
New drug agrees to CHMP
The CHMP has given its stamp of approval to Boehringer Ingelheim’s Juskyd for two lung diseases: idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). The agreement comes two months after Boehringer Chairman Shashank Deshpande expressed dissatisfaction with Europe’s regulatory timeline.
“Why is it possible in one jurisdiction or region and why does it take six months, nine months in Europe?” Deshpande asked.
Jascayd is the first new treatment for IPF in more than a decade, a potentially fatal disease that causes scar tissue to build up 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 last October and expanded it to treat PPF two months later.
Meanwhile, Novartis has won CHMP approval for its oral drug Bijois to treat the rare disease PIK3CA-related overgrowth spectrum (PROS). This approval comes four years after the FDA approved the treatment, which is the first to address the underlying cause of the condition. The CHMP green light is for patients 2 years of age and older.
Additionally, one month after the FDA rejected AbbVie’s new beauty product, CHMP approved the product for glabellar wrinkles after local muscle paralysis. U.S. regulators have given a quick-acting successor to the blockbuster Botox a disfavor, citing manufacturing problems. Injectable treatments last for two to three weeks, so patients can often confidently move on to longer-acting Botox.
NICE hits 180 on Genmab’s Tivdak
In the UK, the National Institute for Healthcare Excellence (NICE) reversed its opinion on Genmab’s cancer drug Tibudac, recommending its use by the National Health Service (NHS) for patients with recurrent or metastatic cervical cancer whose disease has progressed despite previous systemic therapy (PDF).
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Tibdac for this indication in December last year. But two months ago, NICE questioned its cost-effectiveness in its first guidance, saying it was “higher than what would normally be considered acceptable”.
