FDA Updates for the Week of Oct. 4, 2021


Pfizer officially seeks EUA for pediatric COVID vaccine, AstraZeneca seeks EU for COVID-19 prevention, J&J submits data for COVID-19 booster, a gene therapy is approved for leukemia, and Janssen submits Stelara for psoriatic arthritis in children.

Pfizer seeks EUA for COVID-19 vaccine in children.

Pfizer announced on Twitter that it and BioNTech have officially asked for an emergency use authorization (EUA) for its COVID-19 vaccine for children 5 to 11 years of age.

The companies announced positive topline results from the pivotal trial on Sept. 20, 2021, and they began submitting data from this trial to the FDA on Sept. 28.

In the trial, which included 2,268 participants 5 to less than 12 years of age, the vaccine demonstrated a favorable safety profile and elicited antibody responses using a two-dose regimen of 10 μg doses. These results were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age, who were immunized with 30 μg doses. The 10 μg dose was selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to less than 12 years of age.

AstraZeneca seeks EUA for prevention of COVID-19.

AstraZeneca has submitted a request to the FDA for an emergency use authorization (EUA) for AZD7442, its long-acting antibody (LAAB) combination, for the prevention of symptomatic COVID-19.

If granted, AZD7442 would be the first LAAB to receive an EUA for COVID-19 prevention. It is the first LAAB with phase 3 data demonstrating a statistically significant reduction in the risk of developing symptomatic COVID-19 compared with placebo.

AstraZeneca presented positive data from a phase 3 study of its monoclonal antibody treatment for COVID-19 at the 10th Annual IDWeek Virtual Conference, September 29 to October 3. That data showed that AZD7442 reduced the risk of developing symptomatic COVID-19 by 77% compared with placebo, AstraZeneca said when originally announcing the results in August. Greater than 75% of participants presented with co-morbidities associated with an increased risk of severe disease or a reduced immune response to vaccination.

J&J submits data to the FDA to support its COVID-19 booster.

Johnson & Johnson has submitted data to the FDA to support use its COVID-19 vaccine as a booster shot in people 18 years of age and older.

The submission includes recent results from the phase 3 ENSEMBLE 2 study that found a booster of J&J’s COVID-19 vaccine given 56 days after the primary dose provided 94% protection against symptomatic, moderate-to-severe COVID-19 in the United States and 100% protection against severe/critical COVID-19.

Also part of the submission is phase 1/2a data showing that when a booster of the vaccine was given six months after the single shot, antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster. The vaccine, when given as a booster or primary dose, was generally well-tolerated.

FDA approves Tecartus for acute lymphoblastic leukemia.

The FDA has granted approval for Kite’s Tecartus (brexucabtagene autoleucel) for the treatment of adult patients (18 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Kite is a Gilead company.

The agency had previously given the gene therapy breakthrough therapy designation and priority review. Tecartus is the first chimeric antigen receptor (CAR) T-cell therapy approved for adults with ALL. Patients can access Tecartus through 109 authorized treatment centers across the United States.

This approval is the fourth indication for the anti-CD19 CAR T-cell therapy and the first in leukemia. Tecartus uses the XLP manufacturing process that includes T cell enrichment, a necessary step in certain B-cell malignancies in which circulating lymphoblasts are a common feature. Tecartus is also being evaluated in pediatric ALL.

Janssen submits application for Stelara for psoriatic arthritis in children.

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a supplemental biologics license application FDA seeking expanded approval of Stelara (ustekinumab) to treat pediatric patients ages 5 years and older with juvenile psoriatic arthritis.

The submission is based on data extrapolated from nine studies in adult trials in active psoriatic arthritis and adult and pediatric studies in moderate-to-severe plaque psoriasis. A decision from the FDA is anticipated in late 2022.

Stelara targets cytokines interleukin-12 and IL-23, both of which play an important role in inflammation associated with diseases such as psoriatic arthritis.

Stelara is approved in the United States for the treatment of: adults and children 6 years and older with moderate-to-severe plaque psoriasis; adult patients with active psoriatic arthritis; adult patients with moderately to severely active Crohn’s disease or ulcerative colitis.

FDA advisory recommends approval of Takeda’s maribavir.

The FDA’s Antimicrobial Drugs Advisory Committee voted unanimously to recommend use of Takeda’s maribavir (TAK-620) for the treatment of refractory cytomegalovirus (CMV) infection and disease in those who have a resistance ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients. The committee also voted unanimously to recommend use of maribavir for the treatment of refractory CMV infection and disease without genotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients. Both recommendations were based on the results of the phase 2 and phase 3 trials.

A new drug application for maribavir is currently under priority review by the FDA.

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