Sector News

FDA AdComm backs GlaxoSmithKline’s 1-shot P. vivax malaria therapy

July 17, 2018
Life sciences

GlaxoSmithKline is close to ending a six-decade drought in relapse-preventing therapies for Plasmodium vivax—one of the most common forms of malaria—after its new drug tafenoquine cleared an FDA advisory committee.

The panel backed the efficacy of the tafenoquine regimen by 13 votes to zero, and its safety by 12 to one, in P. vivax-infected patients aged 16 or older, after the FDA published briefing documents (PDF) which backed the drug.

The drug’s long half-life in the body means that it can prevent relapse with one dose, unlike current therapy primaquine which needs a daily dose for two weeks, which was also the comparator arm in the main phase 3 trial supporting tafenoquine’s marketing application. That means it should be easier to deliver and improve compliance, particularly in countries with fewer healthcare resources.

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. To read on the go, sign up today to get biotech news and updates delivered right to your inbox!

SUBSCRIBE NOW

GSK developed tafenoquine in partnership with Medicines for Malaria Venture (MMV) to address the need for a drug that can achieved a “radical cure” of this type of malaria—in other words, clear up the infection and prevent it from coming back. It has breakthrough status from the FDA for this indication.

The main endpoint of the trials was relapse-free efficacy six months after dosing, and overall the panel concluded that GSK and MMV’s drug performed as well as primaquine. There were some safety signals to take into account, including two cases of hypersensitivity. Patients prescribed the drug should also be tested for glucose-6-phosphatase dehydrogenase (G6PD) deficiency, as in these individuals it can cause severe anemia. That’s an issue that also affects parent drug primaquine.

  1. vivax kills fewer people than the deadliest malaria parasite P. falciparum but is more widespread—affecting 16 million people in 2013, according to the World Health Organization—and can also cause severe disease and be life-threatening. It has a massive geographic range, with around half of P. vivax cases occurring outside Africa, and the WHO considers this species of the malaria parasite as the main barrier to its goal of eliminating malaria worldwide by 2030.

It’s been 12 years in development and if approved by the FDA will be the first new drug for this indication in 60 years, according to Pauline Williams M.D., GSK’s head of global health R&D, who also spearheaded the company’s development of a chlorhexidine gel product for the prevention of neonatal sepsis.

“Together with our partners, we look forward to the final decision by the FDA,” she said in a statement.

So far, the drug hasn’t been approved anywhere in the world, although it has been submitted for approval in Australia and a decision there is expected in the next few months. Approval in either the U.S. or Australia would help set up registrations in countries where P. vivax is endemic, and it would also open the door for WHO prequalification, which can accelerate uptake.

By: Phil Taylor

Source: Fierce Biotech

comments closed

Related News

November 27, 2022

DSM-Firmenich nutrition and beauty mega-merger edges closer as companies announce Exchange Offer

Life sciences

The new company will have four complementary businesses: Perfumery & Beauty, Food & Beverage/Taste & Beyond, Health, Nutrition & Care and Animal Nutrition & Health, each with strong market positions and expertise to address emerging consumer trends. The businesses will also prioritize environmental sustainability, health and well-being.

November 27, 2022

Merck agrees to acquire Imago for $1.35bn

Life sciences

Merck (MSD) has signed a definitive agreement for the acquisition of all outstanding shares of Imago BioSciences for a total equity price of nearly $1.35bn. A clinical-stage biopharmaceutical firm, Imago focuses on the development of new therapies to treat myeloproliferative neoplasms (MPNs) and other bone marrow ailments.

November 27, 2022

Novo Nordisk expands API capacity

Life sciences

Danish pharma Novo Nordisk has announced plans to invest 5.4 billion Danish kroner to expand its existing facilities in Bagsværd. The project will establish extra R&D capacity for manufacturing APIs to supply the company’s global clinical trials for oral and injectable products. The expansion is expected to be finished in 2024, creating about 160 new jobs.