FDA Accepts sBLA for Actemra for Hospitalized COVID-19 Patients

The FDA has accepted the Genentech/Roche’s supplemental biologics license application (sBLA) and has granted Priority Review for Actemra (tocilizumab) intravenous for the treatment of COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen.

If approved, Actemra would be the first U.S. FDA-approved immunomodulator for the treatment of COVID-19 in hospitalized patients.

The submission is based on results from four randomized, controlled studies that evaluated Actemra for the treatment of COVID-19 in more than 5,500 hospitalized patients. Altogether, the results of these four studies (EMPACTA, COVACTA, REMDACTA and RECOVERY) suggest that Actemra may improve outcomes in patients.

In June 2021, the FDA gave Actemra an emergency use authorization (EUA) and is currently approved for use in 16 countries around the world for defined patients hospitalized with severe or critical COVID-19. In February 2022, the World Health Organization (WHO) prequalified Actemra for patients with severe or critical COVID-19, supporting access to care in low- and middle-income countries.

Since the beginning of the pandemic, more than one million people hospitalized with COVID-19 have been treated with Actemra worldwide, according to Genentech.

In March 2022, the company announced progress in meeting the supply challenges associated with Actemra, but said in a statement that supply of Actemra subcutaneous (SC) formulations (ACTPen and prefilled syringe) remains limited. There may be intermittent periods over the next few months where there the therapy might not be available, the company said.

“We are optimistic that Actemra SC availability will improve in the near future and hope for a return to stability this year,” the company said.

Since its EUA in June 2021, there has been continued challenges associated with supply. As a result of limited supply of Actemra, the FDA in December 2021 announced a temporary policy on the risk evaluation and mitigation strategies (REMS) requirements related to CAR T-cell therapies.

The FDA requires in its REMS for CAR T-cell therapies that a minimum of two doses of Actemra are available on-site for each patient and are ready for immediate administration (within two hours) for patients who experience the life-threatening adverse event.

The regulatory agency said in Decmember they would allow one dose to be available at the time of administration of the CAR T-cell therapy, as long as the facility had access to an addition dose that could be given at eight hours.

Related: Hospital Pharmacists Concerned About Actemra Shortage

Actemra, a humanized interleukin-6 (IL-6) receptor antagonist, is already approved to treat rheumatoid arthritis and other immune conditions.