It was a positive week for the European Medicines Agency’s human medicines committee (CHMP), which recommended the approval of eight new drugs including Takeda’s Fruzaqla and AstraZeneca’s Truqap.
The committee also voted in favor of six new label expansions. While the European Commission has the final authority over new drug approvals, it typically follows CHMP’s recommendations.
The approval recommendations include:
Fruzaqla, or fruquintinib, which has been approved in China since 2018. But last January, Takeda offered Hutchmed $400 million upfront for the rights outside of China, Hong Kong and Macau. The drug was approved in the US in November for previously-treated patients with metastatic colorectal cancer. At the time, global oncology president Teresa Bitetti touted Fruzaqla as the first “chemotherapy-free treatment option approved for patients in the US regardless of biomarker status in more than a decade.”
AstraZeneca’s Truqap also won US approval in November 2023. The drug, also known as capivasertib, is administered in combination with AstraZeneca’s Faslodex for certain patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer. It’s approved for patients with specific alterations in PIK3CA, AKT1 or PTEN, a narrower population than AstraZeneca’s late-stage studies.
CHMP also recommended approvals for Sanofi’s Altuviiio (efanesoctocog alfa) in hemophilia A, Idorsia’s Tryvio (aprocitentan) in hypertension and Urovant’s Gemtesa (vibegron) for patients with overactive bladder syndrome.
Sanofi developed Altuviiio with Sobi, which holds commercialization rights in Europe. The drug would be marketed in Europe as Altuvoct.
Johnson & Johnson once held the rights to Tryvio, but handed them back to Idorsia in September, months before the drug was approved in the US to treat hypertension. In Europe, Idorsia plans on marketing aprocitentan as Jeraygo.
Gemtesa was approved in the US way back in 2020. Pierre Fabre Laboratories licensed the commercialization rights in 2022, then submitted an application to the EMA in May 2023. If approved, it would be marketed as Obgesma.
CHMP’s new drug recommendations also included two biosimilars: one for Biogen’s biosimilar to Genentech’s Actemra, and another for Amgen’s biosimilar to J&J’s Stelara. The committee also gave a thumbs-up to Baxter’s generic formulation of the chemotherapy eribulin.
CHMP also recommended six label expansions:
- Roche’s Alecensa for the adjuvant treatment of resected non-small cell lung cancer
- Bristol Myers Squibb’s Opdivo in combination with cisplatin and gemcitabine for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma
- Roche’s Rozlytrek in patients older than 1 month with solid tumors that have an NTRK gene fusion
- J&J’s Rybrevant as first-line combination therapy for non-small cell lung cancer
- J&J’s Sirturo in certain adults and children older than 5 years who weigh at least 15 kg with pulmonary tuberculosis due to Mycobacterium tuberculosis
- ViiV’s Triumeq for children 3 months and older weighing at least 6 kg with HIV-1