HAT

Sanofi announced Monday that the U.S. FDA has approved its oral sleeping sickness treatment, fexinidazole, in patients age 6 and older and weighing at least 20 kilograms. According to the press release, the approval also nets a tropical disease Priority Review Voucher for Sanofi’s co-developer, the Drugs for Neglected Diseases Initiative. Sanofi and DNDI will share the PRV benefits.

The EMA approved the drug in 2018.

Sanofi announced an extension on Tuesday of its 20-year partnership with WHO on human African trypanosomiasis (HAT), valuing the new commitment at $25 million over the next five years.

The funds will support disease management, population screening, an awareness campaign, capacity building and drug donation, according to a press release.

Sanofi produces the current HAT standard-of-care—the oral, 10-day fexinidazole regimen—and is working with the Drugs for Neglected Diseases…

Mentions:

The Drugs for Neglected Diseases initiative (DNDi) announced Friday that it is working again with Sanofi to improve human African trypanosomiasis (HAT) treatment. DNDi and Sanofi successfully licensed their first 10-day HAT regimen, fexinidazole, in November 2018.

This new collaboration will see DNDi complete clinical development of its novel drug acoziborole—taken as a single dose at the point of diagnosis and currently in Phase 2/3 in the Democratic Republic of the Congo and Guinea.…

The U.S. FDA this week added brucellosis (undulant fever), opisthorchiasis (liver fluke infection) and paragonimiasis (lung fluke infection) to its list of tropical diseases for purposes of priority review voucher awards because of the lack of a “significant market in developed nations” for treatments. Meanwhile, the agency dropped coccidioidomycosis (Valley fever) and clonorchiasis (Chinese liver fluke infection) for the opposite reason.

In other NTD news, researchers from Britain’s…

The Drugs for Neglected Diseases initiative (DNDi) announced this week that the Gates Foundation is giving it a three-year, $29.2 million grant to develop new drugs for human African trypanosomiasis (HAT) and onchocerciasis.

According to the DNDi press release, $15 million will go toward developing acoziborole as the first single-dose oral treatment for HAT and $14.2 million toward onchocerciasis drug development, including a proof-of-concept for two compounds—Bayer’s emodepside and…

Mentions:

The Drugs for Neglected Diseases initiative announced last week that France’s development agency, AFD, has awarded it $8.9 million to support introducing new drugs for sleeping sickness and increasing access to antiretrovirals for HIV-positive newborns and young children, among other efforts.

Mentions:

WHO used its biennial update of the model essential medicines and essential diagnostics lists this week to include new cancer therapies and tests. WHO Director-General Tedros Adhanom Ghebreyesus said in his organization’s press release that the change is a “strong statement that everyone deserves access to these life-saving medicines, not just those who can afford them.”

Of the newly added drugs, 12 out of 28 are for cancer—including Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo…

Sanofi and the Drugs for Neglected Diseases initiative announced today that the Democratic Republic of Congo has become the first country with endemic sleeping sickness to approve its human African trypanosomiasis (HAT) treatment, fexinidazole. According to the press release, a submission is also planned for Uganda and the authorization may pave the way for approval of the 10-day oral treatment in other endemic countries.

Mentions:

Sanofi announced last week that the European Medicines Agency (EMA) has approved its oral sleeping sickness treatment fexinidazole, co-developed with the Drugs for Neglected Diseases initiative.

This is the 10th medicine that EMA has recommended using its Article 58 mechanism, which allows the regulatory authority to assess medicines intended for use outside the European Union.

Sanofi announced today that it has submitted a new drug application to the European Medicines Agency (EMA) for fexinidazole, its oral sleeping sickness treatment co-developed with the Drugs for Neglected Diseases initiative. EMA has accepted the application under its Article 58, which is intended for medicines that will be used outside of the European Union.

Mentions: