Eli Lilly Seeks Emergency Approval For Antibody Treatment
The company says its single-antibody treatment helps higher-risk patients with mild to moderate COVID-19 and that it could have 100,000 doses available in October if the FDA authorizes it. Eli Lilly is also working on a two-antibody treatment and may file for emergency approval in November.
The Hill:
Eli Lilly Asks For Emergency Authorization Of COVID-19 Antibody Treatment
The pharmaceutical company Eli Lilly said Wednesday it has requested emergency authorization from the Food and Drug Administration (FDA) for an antibody treatment for the coronavirus. The company said it had submitted an initial request to the FDA for its antibody treatment, which was derived from a blood sample of a patient who recovered from the coronavirus. The treatment essentially injects a manufactured version of one of the body’s tools for fighting the virus into patients. (Sullivan, 10/7)
Stat:
Eli Lilly Says Its Monoclonal Antibody Cocktail Is Effective Against Covid-19
Eli Lilly said Wednesday a monoclonal antibody treatment is effective in reducing levels of the virus that causes Covid-19 in patients, and also appears to prevent patients from visiting the emergency room or hospital. Lilly had previously released results for a similar treatment using one antibody, which experts viewed as promising. But the new results, of a combination of two antibodies, appear, based on limited data provided in a press release, to be more robust. (Herper, 10/7)
In updates on remdesivir —
USA Today:
Trump, COVID Questions: How Expensive Is Remdesivir? Is He Contagious?
For remdesivir, private insurance companies will pay $520 per vial or $3,120 for a five-day course of treatment, while the company will charge the U.S. government $390 per vial, or $2,340 per patient. As for REGN-COV2, prices aren't set for drugs until they're approved by the FDA. But monoclonal antibodies are usually extremely expensive. Cancer-related monoclonal antibodies often cost nearly $100,000 a year, according to one 2018 study. For COVID-19, monoclonal antibodies are expected to be orders of magnitude cheaper, likely on the order of a few thousand dollars for a single-dose regimen. (Hauck, 10/7)
Reuters:
EU Signs Joint Procurement Contract For Remdesivir Supply
The European Commission said on Thursday it had signed a contract with U.S. drugmaker Gilead GILD.O for the supply of up to 500,000 treatment courses for remdesivir, sharply increasing the supply of the COVID-19 treatment in Europe. The Commission, which has overseen joint purchases of vaccines in the European Union, said there were 37 signatories to the agreement, including all EU countries, six Balkan candidate and potential EU members, Britain and the other European Economic Area countries Iceland, Liechtenstein and Norway. (10/8)
