- Schwan said that Roche has applied for an emergency authorization for the "antibody cocktail."
- Roche can supply the drug in the first quarter of next year.
- Eli Lilly's antibody therapy to treat new coronavirus infection has been authorized by the FDA for an emergency.
In an interview with Bloomberg TV on Friday, Roche Holdings CEO Severin Schwan said that the company is working to rapidly increase the supply of new coronavirus antibody drugs, and the first batch will be delivered in the first quarter of next year. “We’re working hard to ramp up production as fast as we can,” Schwan said.
“No matter what, irrespective of other therapeutics, the demand for antibody cocktails will by far outstrip supply, so we have to make sure we target really the right patient groups.”
“At Roche we’ll be able to provide supply in the first quarter,” he added.
Schwan said that Roche has applied for an emergency authorization for the “antibody cocktail,” developed in cooperation with the American biotech company Regeneron Pharmaceuticals, and that authorization may be obtained “soon.”
He pointed out that Roche can supply the drug in the first quarter of next year. Initial supply is limited and reserved for high-risk patients.
Eli Lilly’s Antibody Therapy
Eli Lilly’s antibody therapy to treat the new coronavirus infection has been authorized by the FDA for emergency use.
According to the announcement on the US Food and Drug Administration (FDA) website, Eli Lilly’s monoclonal antibody therapy, bamlanivimab, for the treatment of mild to moderate coronavirus infections in adults and children, has received emergency use authorization from the FDA.
“The FDA’s emergency authorization of this combination therapy represents an incremental step forward in the treatment of COVID-19 in hospitalized patients, and FDA’s first authorization of a drug that acts on the inflammation pathway,” Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
According to media reports at the end of October, Eli Lilly and the United States reached a preliminary agreement to supply 300,000 bottles of 700 mg of the research neutralizing antibody bamlanivimab (LY-CoV555) at a price of $375 million.
If emergency use authorization from the US Food and Drug Administration (FDA) is obtained, the US government will accept this bamlanivimab. Eli Lilly submitted a request to the FDA in early October to grant the emergency use of bamlanivimab for the treatment of high-risk patients with mild to common new coronary disease.
Eli Lilly said it expects to produce up to 1 million doses of the drug by the end of 2020, of which 100,000 doses can be shipped within a few days of authorization.
David Ricks, Chief Executive Officer of Eli Lilly and Company, said the company is distributing the drug to the countries where it is most needed and will commit to supplying only a few months’ doses at a time to any given country in order to match demand with limited supply.
A few days before reaching an agreement with the U.S. government, the company just stated that data from this study shows that the drug is “unlikely” to help patients with the new coronavirus disease recover from their late stages.
However, the company also emphasized that it believes that this drug is helpful for patients suffering from the early stage of the new coronavirus pneumonia.
Eli Lilly’s drugs are part of a class of treatments called monoclonal antibodies, which are made into immune cells that scientists hope can fight the virus. In addition, other companies, including Regeneron, are also studying antibody therapy.
In fact, the agreement with Eli Lilly is part of the US government’s “Operation Warp Speed” to accelerate the development and distribution of reliable vaccines. The action was created by the government to provide funds for the rapid development and distribution of a new coronavirus vaccine.