FDA Updates for the Week of May 16, 2022

FDA expands EUA for Pfizer/BioNTech COVID-19 booster to children 5 to 11 years.

The FDA has amended the emergency use authorization (EUA) for the Pfizer/BioNTech COVID-19 vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age. The booster is given at least five months after completion of a primary series and is the same dose of the Pfizer-BioNTech COVID-19 vaccine.

To date, more than 8 million 5- to 11-year-olds in the United States have completed a primary series, and 4,500 children this age have participated in the companies’ COVID-19 vaccine clinical trial, according to a press release issued by Pfizer.

The expanded EUA is based on data from the phase 2/3 clinical trial, which showed that a booster dose of the Pfizer-BioNTech COVID-19 vaccine elicited a strong immune response in this age group, generating neutralizing antibodies against both the omicron variant and wild-type SARS-CoV-2 virus regardless of prior SARS-CoV-2 infection. No new safety signals were observed.

FDA clears first at-home combo COVID-19, RSV and flu test.

The FDA okayed the first direct-to-consumer multi-analyte COVID-19 test that can detect SARS-CoV-2, influenza A and B, and respiratory syncytial virus (RSV) simultaneously.

The Labcorp Seasonal Respiratory Virus RT-PCR DTC Test is available without a prescription, so people can self-collect a nasal swab sample at home and then send the sample to Labcorp for testing, FDA said in a news release.

Results are delivered through an online portal, with follow up from a healthcare provider for positive or invalid test results. The home sample collection kit can be purchased online or in a store.

FDA okays Lilly’s novel diabetes drug.

The FDA has approved Eli Lilly’s Mounjaro (tirzepatide) injection — the first drug of its type — to treat type 2 diabetes. Mounjaro has not been studied in patients with a history of pancreatitis and is not indicated for use in patients with type 1 diabetes.

The once-weekly GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist is the first and only FDA-approved GIP and GLP-1 receptor agonist, Lilly said in a news release. Mounjaro will be available in six doses (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg) and will come in Lilly's auto-injector pen with a pre-attached, hidden needle.

Mounjaro was effective at improving blood sugar and was more effective than the other diabetes therapies with which it was compared in clinical studies, the FDA said in a news release.

FDA approves Dupixent for eosinophilic esophagitis.

The FDA has approved Dupixent (dupilumab) to treat patients with eosinophilic esophagitis aged 12 years and older. Eosinophilic esophagitis is an inflammatory disease of the esophagus, causing it to narrow and develop abscesses. People with atopic dermatitis, asthma, or food or environmental allergies have a much greater chance of developing the condition. About 160,000 patients are living with eosinophilic esophagitis in the United States and are currently treated with therapies not specifically approved for the disease.

Dupixent, developed by Regeneron Pharmaceuticals and Sanofi, is the first medicine approved in the United States specifically to treat eosinophilic esophagitis.

Dupixent is also approved to treat moderate-to-severe atopic dermatitis, eosinophilic or steroid-dependent asthma, chronic rhinosinusitis with nasal polyposis.

FDA declines EUA for fluvoxamine for COVID-19.

The FDA has rejected a request for an emergency use authorization made by a physician for the use of fluvoxamine to treat adults with COVID-19 to prevent hospitalization. Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) that is approved by the FDA to treat patients with obsessive-compulsive disorder and depression.

The rationale for fluvoxamine’s use in patients with COVID-19 is based on models that found the drug binds to the sigma-1 receptor on immune cells, reducing inflammatory cytokines.

David R. Boulware, M.D., is an infectious disease physician with the University of Minnesota who submitted the EUA requestion, suggests that fluvoxamine seems an effective low-cost therapy that provides benefit. Boulware, in a letter to the FDA about the agency’s refusal to issue the EUA, said progression to severe disease is a valid clinical trial endpoint that was used in vaccine trials. “The EUA application noted the 36% reduction in progression to severe Covid-19 as per FDA’s definition of severe Covid-19,” he wrote.

FDA issues CRL for bimekizumab for psoriasis.

The FDA has issued a complete response letter (CRL) regarding the biologics license application (BLA) for UCB’s bimekizumab, now called Bimzelx, for the treatment of adults with moderate-to-severe plaque psoriasis.

The regulatory agency indicated that that certain pre-approval inspection observations must be resolved before approval of the application. UCB is cooperating with the FDA and working to address these observations, the company said in a press release.

In October 2021, the FDA missed the assigned Prescription Drug User Fee Action (PDUFA) date because COVID-19 travel restrictions hindered the ability of the FDA to inspect European manufacturing facilities.

Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A and interleukin 17F, two key cytokines driving inflammatory processes.

FDA modifies Dsuvia REMS program.

The FDA has recently modified the Dsuvia Risk Evaluation and Mitigation Strategies (REMS), eliminating the six-month healthcare setting audit requirement and reducing annual healthcare setting audits. Previously the FDA required the manufacturer, AcelRx Pharmaceuticals, to audit all healthcare settings within six months of an initial order, and to then continue to audit all such sites annually thereafter.

The FDA approved Dsuvia (sufentanil), a synthetic opioid, in November 2018 for the management of acute pain severe enough to require an opioid analgesic. It is a sublingual tablet that was designed to provide rapid pain relief and to eliminate dosing errors associated with intravenous administration.

Dsuvia was approved with a REMS program to ensure proper use and administration. The REMS required distribution through certified healthcare settings and required AcelRx to audit these facilities.