The ID Pipeline: FDA Activity From the Week of July 21, 2019

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of July 21, 2019.

FDA Grants QIDP Designation, Fast Track Status to Matinas BioPharma for Cryptococcal Meningitis Treatment

On Thursday, July 25, 2019, the FDA granted Matinas BioPharma Holdings, Inc. Qualified Infectious Disease Product (QIDP) designation and Fast Track status for its proprietary oral amphotericin B product for the treatment of cryptococcal meningitis.

The product, MAT2203, previously received QIDP designation with Fast Track status for 3 other indications, including for the prevention of invasive fungal infections due to immunosuppressive therapy, for the treatment of invasive candidiasis, and for the treatment of invasive aspergillus.

“Cryptococcal meningitis is a life-threatening condition most commonly observed in immunocompromised individuals. It has emerged as one of the most frequent and deadly opportunistic infections in human immunodeficiency virus (HIV) patients,” Jerome D. Jabbour, chief executive officer of Matinas, said in a press release. “These QIDP and Fast Track designations for MAT2203 are another major step forward for this program, positioning Matinas for eligibility for an additional five years of marketing exclusivity in cryptococcal meningitis if MAT2203 is approved by the FDA. We are currently planning to initiate our first clinical study for MAT2203 as a treatment for cryptococcal meningitis, fully funded by the National Institutes of Health (NIH). We view this study as an important demonstration of the capability of our unique drug delivery platform, including the important potential for carrying therapies across the blood-brain barrier which could have far-reaching implications.”

The full press release is available here.

Valneva Secures CEPI Funding for Late-Stage Clinical Development of Single-Dose Chikungunya Vaccine

On Thursday, July 25, 2019, Valneva SE and the Coalition for Epidemic Preparedness Innovations (CEPI) announced a partnership to develop and manufacture a single-dose vaccine for Chikungunya.

Under the deal, CEPI will provide Valneva with $23.4 million for vaccine manufacturing and late-stage clinical development of a single-dose, live-attenuated vaccine (VLA1553) against the virus.

“Valneva is delighted to announce this partnership with CEPI. Chikungunya infection is a major unmet medical need and we believe that our single-shot vaccine is uniquely positioned to provide optimal protection in all outbreak situations for people living in areas where Chikungunya occurs and also for travelers to these regions," Thomas Lingelbach, CEO of Valneva, said in a press release. "We continue to invest heavily in the program and look forward to working with CEPI on the project. We plan to enter the pivotal study phase of our vaccine as soon as possible in close alignment with the US FDA, with the aim of an accelerated approval.”

The full press release is available here.

Sanofi Granted Exclusive Over-the-Counter Rights to Tamiflu in the US

On Tuesday, July 23, 2019, Sanofi signed a strategic deal agreement with Roche for the exclusive over-the-counter (OTC) rights to Tamiflu®. Under the agreement, Sanofi will lead FDA negotiations for the OTC switch and subsequent exclusive marketing, scientific engagement, and distribution of Tamiflu OTC in the United States.

“This is a strategic and important transaction for us as we strive to continually bring innovations to the market,” Alan Main, executive vice president of Consumer Healthcare at Sanofi, said in a press release. “The US market is the largest OTC market in the world and a successful switch of Tamiflu to OTC would support our global cough and cold strategy by expanding into flu with a sustainable point of difference in the market. Tamiflu will offer a significant public health benefit once switched by providing increased access to a safe and efficacious treatment for the prevention and treatment of flu. People would be able to either reduce their chances of getting the flu or, at the first signals, appropriately treat as early as possible during the crucial first 48 hours without having to wait for a doctor’s appointment.”

The full press release is available here.

La Jolla Pharmaceutical Company Granted Orphan Drug Designation for Malaria Treatment

On Tuesday, July 23, 2019, the FDA granted Orphan Drug Designation to La Jolla Pharmaceutical Company for the Investigational Drug Product LJPC-0118 (artesunate) for the treatment of malaria.

In 2 randomized, controlled, clinical studies, LJPC-0118 demonstrated non-inferiority to quinine in reducing mortality in patients with severe falciparum malaria infection.

“The granting of orphan drug status is a significant milestone for the LJPC-0118 program and highlights the significant unmet medical need for the treatment of malaria,” George Tidmarsh, MD, PhD, La Jolla’s president and chief executive officer, said in a press release. “There are currently no approved treatments in the US for patients with severe malaria. We are preparing to file a new drug application later this year and, upon approval, to making this front-line treatment for severe malaria available to the public.”

The full press release is available here.