Takeda's Qdenga nears approval in EU, and beyond, thanks to special regulatory pathway
Among the slate of decisions from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) October meeting came good news for Takeda. A month after the company’s anticipated dengue fever vaccine, Qdenga, won approval in Indonesia after over a decade of research, the vaccine received a positive CHMP opinion.
The committee recommended the approval of the vaccine in Europe and dengue-endemic countries through the special EU-M4all program.
The experts based their opinion on results from five phase 1, 2, and 3 trials that enrolled more than 28,000 children and adults. The company's largest trial, Tides, featured four-and-a-half years of follow-up data, showing that throughout that time, Qdenga prevented 84% of hospitalized dengue cases and 61% of symptomatic dengue cases in the overall population.
Takeda's dengue shot protects against all four dengue serotypes and safe and well-tolerated, the studies found.
Now all that’s left for the vaccine to launch in Europe and elsewhere is marketing authorization from the EMA, which the company expects in the coming months, according to a recent statement.
The company is ready to launch the vaccine with a stocked inventory, program head Derek Wallace told Fierce Pharma after the Indonesia approval. It’s the perfect time to get the vaccine out, as the disease, which is one of the World Health Organization’s 2019 top 10 threats to global health, is now 30 times more prevalent than it was 50 years ago and is found in 120 countries, he noted.
Dengue is one of the primary causes of hospitalization in children in much of the world, Wallace said at the time.
Takeda will hold an investor event in December to provide more details on commercial planning, as well as updates on the regulatory process.
The CHMP recommended 10 other medicines at the meeting. Novartis’ radiotherapy Pluvicto, which the company thinks could be a $2 billion launch, scored a recommendation in certain patients with prostate cancer.
Then there was Spevigo, Boehringer Ingelheim’s drug to treat generalized pustular psoriasis, a rare skin condition with painful flareups that can cause heart failure or sepsis. Spevigo was the first drug to score FDA approval for the condition in early September. Livmarli, Mirum Pharmaceutical’s Alagille syndrome treatment that also has over a decade of research behind it, got a CHMP nod as well.
Oct 14, 2022
