India committee shoots down Dengvaxia trial waiver

Sanofi Pasteur

An India health ministry panel shot down hopes by Sanofi ($SNY) for a waiver on a large-scale trial for dengue vaccine Dengvaxia--originally raised in January by a special committee that advises the Drug Controller General of India (DCGI), which recommended conditional market authorization.

But in a three-step review process, the top health ministry committee said the "evidence in the present case is not sufficient to waive conduct of clinical trial in the country," according to the Economic Times. The committee chairman, health ministry secretary B.P. Sharma, was joined in the review by Indian Council of Medical Research Soumya Swaminathan, director general of health services Jagdish Prasad, and DCGI G.N. Singh.

The Philippines was the first to approve and launch a public vaccination campaign with Dengvaxia last month. Three other countries--Brazil, Mexico and El Salvador--have approved the vaccine developed by Sanofi Pasteur to prevent all four types of dengue fever--although at varied levels of efficacy.

In the preliminary nod, the Subject Expert Committee to the DCGI said approval would be timely given a recent outbreak of cases in the region, and several other countries in the area--particularly Southeast Asia--but added that market authorization should only cover the age group of 18-45 years and come with a condition to conduct a Phase IV clinical trial in a time bound manner.

A Sanofi spokeswoman said the company would continue to work on the regulatory pathway to get the vaccine in use in India.

"Given the urgency of dengue in India, we are optimistic that we can work with the Indian regulatory authorities to find the best regulatory solution that allows us to increase the clinical data on our dengue vaccine in the Indian population, without delaying access," a Sanofi India spokeswoman told the newspaper.

On the first quarter earnings call, Sanofi CEO Olivier Brandicourt said Dengvaxia sales reached €19 million based on the campaign in the Philippines and that the company recently submitted a "dossier for approval” for the first-in-its-class dengue vaccine to European regulators.

Also in April, the World Health Organization recommended the vaccine be part of control strategies in countries where dengue is endemic.

- here's the story from the Economic Times

Suggested Articles

Pfizer has scored FDA approval for its Humira biosimilar, but it can't launch the product for several years under a patent settlement.

The 3-2 vote on the deal was split along the party lines, spelling trouble for future biopharma M&A deals should Democrats move into the White House.

Recipharm has been building its capabilities in sterile injectable and inhalation drugs. Now it is buying a CDMO that manufactures devices for both.