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 is marketing authorization from the European Commission, which the company expects by December, program head Derek Wallace said in an interview with Fierce Pharma. The company is ready to launch the vaccine with a stocked inventory and expects to start the rollout in Indonesia early next year.
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. It’s a disease that “continues to get more burdensome” despite the efforts to curb it, Wallace said. The public health community is “really crying out for a vaccine that can be used as broadly as this,” he added, noting the broad age range the vaccine will protect.
“We’re looking forward to learning how best to use this vaccine in tackling a very complex, globally important public health emergency,” Wallace said.
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.
Editor's Note: The story has been updated with additonal comment from Takeda's Derek Wallace.