Here is a look at infectious disease-related US Food and Drug Administration news from the week of September 15, 2019.
Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of September 15, 2019.
FDA Approves Expanded Indications for 2 HIV Therapies
On Friday, September 20, 2019, the FDA approved 2 supplemental New Drug Applications (sNDA) for doravirine (Pifeltro) and doravirine/lamivudine/tenofovir disoproxil fumarate (Delstrigo). The approval allows treatment-experienced adults living with HIV, who are virally suppressed and have no prior history of treatment failure, to switch to either of the treatment options. The approval was granted to Merck.
Doravirine is a 100 mg, once-daily, non-nucleoside reverse transcriptase inhibitor (NNRTI), and doravirine/lamivudine/tenofovir disoproxil fumarate is a once-daily fixed-dose combination tablet of 100 mg doravirine, 3TC/300 mg lamivudine, and TDF/300 mg tenofovir disoproxil fumarate. Both were first approved by the FDA in August 2018 for adult patients with no documentation of past antiretroviral therapy.
The full article is available here.
FDA Approves Roche's Cobas Babesia Test, Which Can Detect 4 Species of the Parasite in Individual Blood Donations
On Friday, September 20, 2019, the FDA approved Roche's cobas Babesia test, a whole blood test to screen individual blood donations for Babesia with the cobas 6800/8800 Systems.
The Babesia parasite cannot be detected in traditional plasma or serum samples, but the cobas Babesia test can identify 4 common species of the parasite.
“We are dedicated to helping save patients’ lives by providing advanced solutions to enable the protection of the global blood supply from infectious diseases. With the approval of Roche’s first whole blood test used in blood screening we can help healthcare professionals further diminish potential risks of infection from transfused blood products,” said Thomas Schinecker, CEO Roche Diagnostics, in a press release. “In addition, we hope to help customers improve their lab efficiency by simplifying sample prep while ensuring maximum detection of infectious pathogens in the blood and the safety of the blood supply for the patients we serve.”
The full press release is available here.
FDA Accepts Biologic License Application for Merck's Ebola Vaccine
On Tuesday, September 17, 2019, the FDA accepted a Biologic License Application for the investigational Ebola vaccine V920, Merck announced. The vaccine was also granted priority review for the prevention of Ebola Zaire virus.
The vaccine, which is also referred to as rVSV-ZEBOV-GP, has been deployed for use in the ongoing Ebola outbreak in the Democratic Republic of the Congo. In July 2016, the vaccine was granted a Breakthrough Therapy Designation by the FDA.
According to Merck, the vaccine was initially engineered by scientists from the Public Health Agency of Canada’s National Microbiology Laboratory and then licensed to a subsidiary of NewLink Genetics Corporation. During the western Africa Ebola outbreak in 2014, Merck licensed the vaccine and began working with external collaborators to bolster a clinical development program.
The full story is available here.
Verrica Pharmaceuticals Submits New Drug Application to FDA for Molluscum Contagiosum Treatment
On Monday, September 16, 2019, Verrica Pharmaceuticals submitted a New Drug Application to the FDA for VP-102 (cantharidin 0.7% Topical Solution) for the treatment of molluscum contagiosum.
Two Phase 3 trials (CAMP-1 and CAMP-2) demonstrated the safety and efficacy of VP-102 comparable to placebo in patients 2 years of age and older. There are currenly no FDA-approved treatments for the infection.
“Molluscum is a viral skin infection that is highly contagious, spreads rapidly, and is significantly undertreated, with no FDA-approved therapeutic options,” Ted White, president and Chief Executive Officer of Verrica, said in a press release. “The NDA submission potentially brings us one step closer to our goal of providing patients—particularly children and their caregivers—with a safe and effective therapy for molluscum with our proprietary single-use applicator. If approved, VP-102 has the potential to become the standard of care for this disease.”
The full press release is available here.