Genentech Announces FDA Approval to Treat Severe COVID-19 Cases

We at Rondo-Pak are proud to be an integral link in the Supply Chain of the pharmaceutical industry. In addition to providing the packaging for flu vaccines in the Northern Hemisphere, we are a supplier to numerous major pharmaceutical companies worldwide, and we provide packaging for many of the prescription and over-the counter products that are part of everyday life.

In the current pandemic environment we are supplying several companies that  are; performing clinical trials for an urgently needed vaccine against COVID-19, providing test kits for the virus, and ramping up production of needed pain relievers and drugs being used to help shorten the illness associated with the virus.

Genentech has recently received FDA approval for clinical trials of Actemra to treat hospitalized patients with severe COVID-19 pneumonia. Read an excerpt from their press release below;

“Genentech Announces FDA Approval of Clinical Trial for Actemra to Treat Hospitalized Patients With Severe COVID-19 Pneumonia

Genentech will also provide 10,000 vials of Actemra to the U.S. Strategic National Stockpile. Current U.S. supply of Actemra for approved indications is not expected to be impacted

South San Francisco, CA — March 23, 2020 —

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today the U.S. Food & Drug Administration (FDA) has approved a randomized, double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to evaluate the safety and efficacy of intravenous Actemra® (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia.

Additionally, to further support U.S. COVID-19 response efforts, Genentech will provide 10,000 vials of Actemra to the U.S. Strategic National Stockpile for potential future use at the direction of the U.S. Department of Health and Human Services (HHS). The company has robust business continuity and mitigation strategies in place, and current U.S. supply of Actemra for approved indications is not expected to be impacted. Genentech has also been working with distributors to manage product supply to enable both Genentech and our distribution partners to quickly fill orders to meet patient needs.

‘We thank the FDA for rapidly expediting the approval of this clinical trial to evaluate Actemra in critically ill patients suffering from pneumonia following coronavirus infection and we’re moving forward to enroll as quickly as possible,’ said Alexander Hardy, chief executive officer of Genentech. ‘Conducting this clinical trial in partnership with BARDA and providing Actemra to support the national stockpile, through the efforts of Secretary Azar and HHS, are important examples of how the U.S. government the biotechnology industry and healthcare communities are working together in response to this public health crisis.’

To date, several independent clinical trials have begun globally to explore the efficacy and safety of Actemra for the treatment of patients with COVID-19 pneumonia. However, this new trial is vital because there are no well-controlled studies and limited published evidence on the safety or efficacy of Actemra in the treatment of patients suffering from COVID-19. In addition, Actemra is not currently approved for this use by the FDA.”

To read the full press release, visit the Genentech website.