CHMP issues positive opinion for two high-profile drugs in latest batch of recommendations – Endpoints News
As for the European Medicines Agency’s Medicines Review Board, known as the CHMP, any positive opinion it gives to a drug is almost certain to be approved across the EU. And the committee just handed out notices to a batch of 10 drugs, including two with higher profiles.
The Committee for Medicinal Products for Human Use, aka CHMP, has recommended seven branded and three generic drugs for marketing authorization in the EU. And although the European Commission must approve before these drugs are put on the market, it is rare for the commission to go against the choices of the committee.
The first is tabelecleucel, the Ebvallo-branded allogeneic T-cell therapy manufactured by Atara Biotherapeutics, for a specific subgroup of patients with post-transplant lymphoproliferative disease who are Epstein-Barr virus positive. The disease, also called EBV+ PTLD, is a rare complication that can occur after solid organ or hematopoietic stem cell transplantation.
Atara said in a statement after the positive opinion that if the drug is approved, French pharmaceutical company Pierre Fabre will lead marketing efforts on the continent. The expected deadline for the signature of the European Commission is by the end of the year.
This latest news marks a positive turn for Atara after it was revealed in August that it would lay off 77 employees in California as part of a slimming plan announced in its second quarter report.
Some of what Biotech said it would focus on to reduce cash burn would include focusing on regulatory filings in the EU and US while seeking a commercial partner for tabelecleucel in the States. -United. This is in addition to the 20% reduction in its workforce to extend the company’s cash trail through the first quarter of 2024.
While Atara is close to getting its T-cell therapy approved in the EU, it still has some time to go in the US, as it has yet to file a BLA with the FDA. CEO Pascal Touchon said in a statement in August that the FDA “has recommended a possible route to tab-cel BLA filing without the need for a new clinical study.”
The CHMP also gave a positive recommendation to Qdenga, Takeda’s live, attenuated tetravalent dengue vaccine.
Two months ago in Indonesia, the vaccine was also approved to treat what the WHO called one of the top 10 health problems.
The vaccine was designed to prevent dengue, regardless of previous exposure. This warning against prior exposure is significant because Sanofi’s dengue vaccine, called Dengvaxia, carried a life-threatening risk for those who have never had dengue infection. The Philippine government halted a mass vaccination campaign after it purchased $70 million worth of vaccine and sued Sanofi, which admitted the risks.
Other drugs the committee has approved so far this month, making 80 positive opinions so far this year, include Novartis’ cancer drugs Locametz and Pluvicto for prostate cancer, Boehringer Ingelheim’s Spevigo for treat flare-ups in adults with pustular psoriasis, as well as the generic dimethyl fumarate form of Teva. to treat multiple sclerosis.