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The ID Pipeline: FDA Activity From the Week of October 13, 2019

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of October 13, 2019.

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of October 13, 2019.

FDA Approves Baloxavir Marboxil for Patients at High Risk of Flu Complications

On Thursday, October 17, 2019, the FDA approved a supplemental New Drug Application for baloxavir marboxil (Xofluza) for the treatment of influenza in individuals who are at increased risk of developing flu-related complications.

Baloxavir marboxil is a first-in-class, 1 dose oral agent that was first approved by the FDA in 2018 for the treatment of acute, uncomplicated influenza in individuals 12 years and older, who have been symptomatic for less than 48 hours. The medication had a novel proposed mechanism of action that inhibits polymerase acidic endonuclease, an enzyme essential for viral replication. When it was approved in 2018, it became the first new antiviral to treat influenza in 20 years.

“With the flu season rapidly approaching, we can now offer Xofluza as the first and only FDA-approved treatment option indicated specifically for those at high risk of flu complications,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Genentech said in a statement. “People with chronic conditions such as asthma, heart disease and diabetes are at higher risk of developing serious complications from the flu, so it is critical that these patients speak with their health care providers about possible treatment at the first signs and symptoms of the disease.”

The full article is available here.

Paratek Withdraws EMA Marketing Application for Nuzyra for ABSSSI, CABP

On Thursday, October 17, 2019, Paratek Pharmaceuticals, Inc. announced withdrawal of its Marketing Authorization Application to the European Medicines Agency (EMA) for omadacycline (Nuzyra).

The EMA has recommended approval for Nuzyra for the treatment of acute bacterial skin and skin structure infections (ABSSSI) but not for community-acquired bacterial pneumonia (CABP). A second study is required for the CABP indication, the EMA ruled, following in line with European Union guidance, which recommends 2 phase 3 studies per indication.

The company plans to re-submit the application to the EMA following completion of the planned Post-Marketing Approval CABP study already agreed upon with the FDA.

The full press release is available here.

ViiV Submits sNDA for Dovato in Virologically Suppressed Adults With HIV-1

On Wednesday, October 16, 2019, ViiV Healthcare submitted a supplemental New Drug Application (sNDA) to the FDA for dolutegravir (DTG) and lamivudine (3TC) (Dovato) as a switch treatment for virologically suppressed adults with HIV-1 inefction.

Dovato is currently approved in the US as a complete, once-daily, single-tablet regimen for treatment-naive adults with HIV-1 infection with no antiretroviral treatment history and with no known resistance to either dolutegravir or lamivudine. The filing is supported by results from the phase 3 TANGO study.

“The TANGO study shows virologically suppressed adults with HIV-1 looking to switch their treatment can get the efficacy of a 3-drug [tenofovir alafenamide fumarate]-containing regimen with Dovato, a two-drug regimen," Kimberly Smith, MD, head of Research & Development at ViiV Healthcare, said in a statement. "Today’s submission takes us a step closer toward offering this option for virologically suppressed adults living with HIV who are looking to treat HIV with fewer drugs.”

The full press release is available here.

Novavax Initiates Phase 3 Trial of NanoFlu Influenza Vaccine for Adults Aged 65 and Over

On Tuesday, October 15, 2019, Novavax, Inc. announced the initiation of a pivotal phase 3 clinical trial for NanoFlu, a recombinant quadrivalent seasonal influenza vaccine candidate for adults aged 65 and over.

The trial will evaluate the safety and immunogenicity of NanoFlu with Novavax's proprietary Matrix-M adjuvant compared with a US-licensed quadrivalent influenza vaccine. Top-line data is expected in the first quarter of 2020.

“This is an important step forward in Novavax’ efforts to gain approval for NanoFlu, which we believe will better protect older adults from the serious medical complications of influenza through our novel vaccine technology,” said Stanley C. Erck, president and CEO of Novavax, said in a statement. “With current vaccine efficacy at 12 percent in older adults, NanoFlu may address a major unmet need that represents a $4 billion market globally.”

The full press release is available here.

Matinas BioPharma Initiates Phase 2 EnACT Study for the Treatment of Fungal Cryptococcal Meningitis

On Monday, October 14, 2019, Matinas BioPharma Holdings, Inc. announced the initiation of the phase 2 EnACT study evaluating MAT2203 for induction and maintenance therapy in patients with HIV and cryptococcal meningitis.

“We are extremely pleased to advance clinical development of MAT2203 for the treatment of cryptococcal meningitis,” Theresa Matkovits, PhD, chief development officer of Matinas, said in a statement. “Antifungal resistance poses a major threat to the lives of vulnerable immunocompromised patients, and MAT2203 could provide an invaluable oral and safe treatment for severe fungal infections in these patients. EnACT is an important study to highlight the benefits provided by our lipid nano-crystal (LNC) drug delivery technology and is a key part of our strategy to ultimately position MAT2203 as a potential first-line therapy for the treatment of a variety of invasive fungal infections, including cryptococcal meningitis. We plan to provide updates on EnACT later in 2019 and over the course of 2020, as we advance past the maximum tolerated dose (MTD) portion of this study and advance from cohort-to-cohort during the efficacy stages.”

The full press release is available here.