Pfizer Adds Four Lots to Chantix Recall
August 16, 2021Jemperli Receives Accelerated Approval to Treat Solid Tumors
August 17, 2021August 16, 2021 – Genentech, the manufacturer of Actemra® (tocilizumab), has announced a global shortage of the drug's intravenous (IV) form due to high demand driven by COVID-19 and a surge in cases as a result of slowing vaccination rates and the Delta variant of the COVID-19 virus, SARS-CoV-2.
- Genentech reports a more than 400% increase in demand for Actemra IV compared to pre-COVID- 19 levels. The company is taking steps to restore adequate supply but expects additional shortages to occur if the COVID-19 pandemic continues to surge.
- The U.S. FDA granted emergency use authorization (EUA) to Actemra IV on June 24, 2021, to treat hospitalized individuals at least two years of age diagnosed with COVID-19 and receiving systemic corticosteroids plus supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.
- Actemra IV has been FDA approved since 2010, with indications including the treatment of rheumatoid arthritis, giant cell arteritis, systemic sclerosis-associated interstitial lung disease, polyarticular juvenile idiopathic arthritis, and cytokine release syndrome. Shortages could affect patients diagnosed with these conditions as well as patients diagnosed with COVID-19.
- Although Actemra is also available for subcutaneous injection, this form is not authorized for the treatment of COVID-19.