Responding to the global need for COVID-19 treatments, Gilead Sciences Inc., of Foster City, Calif., is donating its existing remdesivir supply, which is about 1.5 million individual doses, for compassionate use, expanded access, clinical trials and for broader distribution following regulatory authorizations. The donated doses are to be used for treating patients with severe COVID-19 symptoms, through daily intravenous infusions in a hospital setting. Depending on the optimal duration of treatment, which is being studied in clinical trials, the supply could treat more than 140,000 patients. As raw materials with long lead times become available for manufacture, Gilead said it intends to produce more than 500,000 treatment courses by October and more than 1 million treatment courses by the end of the year. “To help us meet and exceed this goal, we are building a geographically diverse consortium of pharmaceutical and chemical manufacturers to expand global capacity for raw materials and production,” Gilead said. The company has taken steps to shorten the manufacturing time for remdesivir from one year to six months. Meanwhile, the EMA’s human medicines committee (CHMP) is encouraging Gilead to make its coronavirus candidate remdesivir available “in a fair and transparent way” to EU member states wanting to take part in international clinical trials or to treat patients with COVID-19 in compassionate use programs. CHMP’s recommendations on the use of remdesivir are intended to ensure a common approach regarding the criteria and conditions of the use of the investigational drug in the EU. The recommendations describe which patients may benefit from the drug, explain how to use it and provide preliminary information on remdesivir’s safety. Meanwhile, with some EU member states starting to see shortages of certain drugs used in treating COVID-19, the EU Executive Steering Group on Shortages of Medicines Caused by Major Events is setting up an industry single point of contact (i-SPOC) system to fast-track interaction on shortages between manufacturers and the steering group. Using i-SPOC, each drug company will report directly to the EMA about anticipated shortages or current shortages of critical medicines used to treat the coronavirus. The system is to be used for both centrally and nationally authorized medicines, but manufacturers also will continue reporting shortages to the appropriate national competent authorities. In addition to the i-SPOC system, the EMA said it is considering other mitigation measures such as regulatory actions to support increased manufacturing capacities by accelerating the approval of a new manufacturing line or site. The steering group also is considering areas where regulations could be applied with greater flexibility during the pandemic to secure the supply of critical medicines. Regulators are working with industry to increase the production capacity for all drugs used in the pandemic, especially those at risk of supply shortages. The EMA said it will provide more information on efforts to mitigate shortages in a question-and-answer document that’s under development.
The U.K.’s National Institute for Health and Care Excellence (NICE) Saturday issued four COVID-19 guidelines that cover the management of patients with severe asthma, pneumonia, rheumatological autoimmune, inflammatory and metabolic bone disorders, and the management of COVID-19 symptoms. The new guidelines are designed to maximize patient safety while making the best use of National Health Service resources. The guideline on pneumonia notes that as COVID-19 becomes more prevalent, pneumonia cases are more likely to be viral than bacterial, so antibiotics will not be effective. Thus, NICE is recommending that antibiotics only be used to treat pneumonia when bacteria is the likely cause.
Given the lockdown in place in India due to the COVID-19 pandemic, Drugs Controller General V.G. Somani issued a circular allowing the Central Drugs Laboratory (CDL) to carry out lot release activities for domestically manufactured vaccines by reviewing the summary lot protocol on a case-by-case basis. Manufacturers should email the summary lot protocol for each batch/lot to the CDL, along with a certificate of analysis and a commitment to recall the vaccine should quality failures arise. However, the CDL can decline to issue a release certificate if it considers the information insufficient, Somani said. Once the situation returns to normal and logistics are restored, manufacturers will be required to submit samples to the CDL following the usual procedures.
In looking at 637 new drug applications (NDAs) and biologic license applications submitted to the FDA from fiscal 2014 through fiscal 2018, the U.S. Government Accountability Office (GAO) found that although review times varied across the agency’s drug divisions, the FDA met its goal of completing 90% of the reviews within specified deadlines. The variance in division review times can be attributed to the proportion of drugs each division evaluates that qualify for a six-month priority review; involve a new molecular entity, which adds two months to a review; or has a major amendment while the NDA is under review. Another factor is the number of drugs a division reviews that qualify for expedited programs for drugs intended to treat serious or life-threatening conditions. For example, the GAO report said, 6% of the NDAs reviewed by the dermatology and dental division had a priority designation, compared with 56% for the anti-infective division. Since divisions such as the oncology unit generally regulate drugs for conditions that are more likely to be serious or life-threatening, they evaluate more drugs that qualify for priority review and other expedited programs.
Fulfilling a commitment it made in the 2017 PDUFA and BsUFA agreements, the FDA released a report providing options and recommendations for a new method to accurately assess changes in the resource and capacity needs of its drug and biosimilar biologic review programs. Comments on the report, which was produced by Booz Allen Hamilton, should be submitted to Docket No. FDA-2020-N-0989 by May 6.