Last week, AstraZeneca and Merck filed emergency use authorization (EUA) requests for their COVID-19 drugs. The FDA provided information to the public about a database repository of gene variants and associated conditions. The U.S., along with 135 other countries, agreed on a global minimum tax of 15%. Please see details for these and other supply chain developments below:
- On October 5, AstraZeneca filed an EUA application for its long-acting antibody (LAAB) COVID-19 prophylaxis, AZD7442, consisting of tixagevimab and cilgavimab. Although the LAAB combination is being investigated for both prophylactic and treatment purposes, the EUA request was for its prophylactic use against symptomatic COVID-19. Two Phase III trials demonstrated a relative risk reduction of symptomatic COVID-19 by 77% and 33%. The data suggest the drug is also effective against variant strains. On October 11, AstraZeneca also issued a press release that revealed the high-level results of another Phase III trial. The trial showed a reduction in the rates of severe COVID-19 or death in the treatment group, compared to the placebo group, in non-hospitalized participants with mild-to-moderate symptoms.
- On October 5, the FDA issued a final rule on the medical device De Novo classification process. The rule establishes procedures and criteria for the submission and withdrawal of a De Novo request and how the FDA will evaluate the request. Based on the new rule, the agency updated the following guidance documents:
- Final guidance “FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals” provides sponsors with information on decision points and timelines that the FDA will adhere to when reviewing a De Novo request.
- Final guidance “De Novo Classification Process (Evaluation of Automatic Class III Designation)” provides guidance to sponsors whose device is automatically classified as type III based on a determination that the device was not substantially equivalent to a predicate device through the 510(k) process.
- Final guidance “User Fees and Refunds for De Novo Classification Requests” provides sponsors with information on which De Novo classification requests require fees, the requests that are exceptions, and the process for refunds.
- On October 7, the FDA’s Center for Devices and Radiological Health issued a description of the Public Human Genetic Variant Databases—a repository of genetic variants and correlating diseases or conditions. The FDA’s goal is to help manufacturers develop tests for these diseases or conditions by providing FDA-recognized databases that contain data and assertions, which can be used to support the FDA’s regulatory review. The FDA considers the available databases scientifically valid.
- On October 8, the U.S., along with 135 other countries, endorsed a global minimum tax rate on corporations of 15%. Multinational companies have been shifting business infrastructure and interests to foreign countries with the lowest tax requirements. Countries with a more stringent tax code, such as the U.S., may benefit. The goal is to keep business interests in their home countries and stimulate local economies.
- On October 11, Merck filed an EUA application for its oral COVID-19 antiviral drug, molnupiravir. The application comes after the interim results for the Phase III clinical trial demonstrated a positive benefit: severe hospitalization and death rates were reduced in the treatment group. If authorized, the drug would be the first oral antiviral medication to treat COVID-19 that patients can take at home.
- On October 12, the FDA announced it was withdrawing three guidance documents: “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19),” “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency,” and “Temporary Policy for Manufacture of Alcohol for Incorporation into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19).” Manufacture of the affected products must cease by December 31, 2021 and distribution by March 31, 2022. The agency determined that the emergency need for the temporary orders no longer exists because supply of alcohol-based sanitizers by “traditional” manufacturers can meet the needs of the demand.
Please do not hesitate to contact us if you have any questions about these developments.