To increase demand for products during the novel coronavirus pandemic, the US Food and Drug Administration (FDA) has already approved at-home testing and investigated the effectiveness of malaria pills and other antiviral drugs to treat Covid-199.
More recently, the FDA announced regulatory approval for the first treatment for Covid-19. Dive into this week’s update for more details on the actions taken by the FDA in the ongoing response to the Covid-19 pandemic.
FDA approves first treatment for Covid-19
On October 22, the FDA approved the antiviral drug Veklury for use in adult and pediatric patients for the treatment of Covid-19 requiring hospitalization. Veklury is the first treatment for Covid-19 to receive FDA approval.
This approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization originally issued on May 1, 2020, but the FDA has advised that Veklury is authorized for treatment in hospitalized patients, adults and pediatric patients 12 years of age and older and weighing at least 40kg.
The approval of Veklury was supported by the agency’s analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe Covid-19.
Stephen M. Hahn, MD, FDA Commissioner, said: “The FDA is committed to expediting the development and availability of Covid-19 treatments during this unprecedented public health emergency. The approval [of Veklury] is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the Covid-19 pandemic.
“As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will to continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”
Takeda and Moderna join forces to expand Covid-19 vaccine supply in Japan
A three-way agreement between Takeda, Moderna and the Government of Japan’s Ministry of Health Labour and Welfare (MHLW) plans to bring mRNA-1273, Moderna’s Covid-19 vaccine candidate, to Japan.
In the first half of 2021, pending licensure of mRNA-1273 in Japan, Takeda has said it will aim to import and distribute 50 million doses to support supply preparedness in Japan. Under the terms of the new agreement with the MHLW and Moderna, Takeda will be responsible for securing the necessary regulatory approvals prior to distributing 50 million doses of Moderna’s Covid-19 vaccine candidate in Japan.
News of the partnership followed Takeda’s announcement in August 2020 that it is establishing the capability to manufacture Novavax’s Covid‑19 vaccine candidate at its facilities in Japan to provide long-term supply to the Japanese population. Takeda’s efforts to bring Moderna’s and Novavax’s Covid-19 vaccine candidates to Japan have been supported by the MHLW and the Japan Agency for Medical Research and Development.
Rajeev Venkayya, MD, President of the Global Vaccine Business Unit at Takeda, said: “Takeda is collaborating with the Japanese Government and vaccine developers to provide rapid and sustained access to Covid-19 vaccines in Japan.
“We have chosen to work with Novavax and Moderna, both of which have promising vaccine candidates, and will continue to support the global response to Cobid-19 through research and development efforts across Takeda.”
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