Sanofi Is Aiming For European Accelerated Assessment For Sleeping Sickness Drug
Executive Summary
Sanofi will this week learn whether fexinidazole, the drug the company is developing for sleeping sickness, will be evaluated quickly once it files for approval. The European Medicines Agency’s CHMP is considering this week whether to grant the company’s request for accelerated assessment.
Sanofi should learn soon whether or not the European Medicines Agency ‘s CHMP will accept the firm’s application for accelerated assessment for its sleeping sickness drug fexinidazole. The committee is this week deciding the matter, a positive outcome for the firm would bring the goal of eradicating the disease closer.
Fexinidazole would be evaluated under the Article 58 procedure for drugs intended for developing countries.
The EMA’s accelerated assessment pathway cuts the authorization process down from 210 days to 150 days. This pathway is available for drugs that are of major interest for public health and therapeutic innovation. Fexinidazole would be the first fully oral treatment for treating both stage one and stage two sleeping sickness, making administration much easier. The current diagnosis and treatment paradigm is complicated and includes systemic lumbar punctures for each patient in order to assess the stage of the disease and which treatment should be administered.
“The WHO has, as an objective, the elimination of sleeping sickness as a public health problem by 2020. Fexinidazole could be a major asset to reach this objective” – Sanofi
Sanofi has been working with the Drugs for Neglected Diseases initiative (DNDi) to develop the drug since 2009. “It complements the partnership we have had with the World Health Organization since 2001, which includes the donation of the necessary medicines to fight sleeping sickness,” said the firm. One of the aims of the partnership is to eradicate sleeping sickness altogether. Sanofi already produces three of the five drugs available for the disease, also known as human African trypanosomiasis. They are pentamidine, eflornithine, melarsoprol. Sanofi will donate fexinidazole too, should it win approval.
Sanofi says that timelines for filing for marketing authorization are still under consideration, but that it is “keen to bring a solution to patients as soon as possible.” The EMA advises companies that accelerated assessment applications are made “at least two to three months before submitting the marketing-authorization application.”
Sleeping sickness, a parasitic disease transmitted by tsetse fly bites in sub-Saharan Africa, is fatal if it is not treated. The number of cases is declining. In 2001, when Sanofi first partnered with the WHO, there were over 40,000 cases. In 2015, there were fewer than 3,000 in 2015, according to Sanofi. “The WHO has, as an objective, the elimination of sleeping sickness as a public health problem by 2020. Fexinidazole could be a major asset to reach this objective,” the company told the Pink Sheet.
The Sanofi product is one of two products that the CHMP is assessing with regard to accelerated assessment. The other is Jazz Pharmaceuticals‘s Vyxeos (cytarabine, daunorubicin) for acute myeloid leukemia. (Also see "New Treatments For Psoriasis, Ovarian Cancer And MS Seeking CHMP Thumbs Up This Week" - Pink Sheet, 13 Sep, 2017.) .
From the editors of the Pink Sheet.