COVID-19 Roundup: News from Lilly, Gilead, Roche, Amgen, AstraZenecaBy
Lilly delays new clinical studies due to COVID-19; Gilead requests rescinding orphan-drug status and updates access for remdesivir, its investigational COVID drug.
Lilly Delaying New Clinical Studies Due to COVID; Supporting Drive-Through Testing
Eli Lilly and Company has provided an update on the company’s clinical trial activities in light of the novel coronavirus (COVID-19) pandemic. The company reports that it will delay most new study starts and pause enrollment in most ongoing studies. Lilly is continuing ongoing clinical trials for patients who are already enrolled.
“Lilly is working hard to alleviate some of the pressure that the global COVID-19 pandemic has placed on our healthcare system,” said Tim Garnett, Lilly’s Chief Medical Officer in a March 23, 2020 company statement. “We have repurposed our laboratories to conduct diagnostic testing for patients and we are researching potential therapeutics. In the interest of helping to ensure patient safety and minimizing further stress on the system, Lilly has also decided to take several proactive steps in regard to our clinical trial activities around the world during the COVID-19 pandemic,” he said in the statement “By delaying most new study starts and pausing enrollment of new patients or healthy volunteers in most ongoing studies, we hope to ease the burden on participating healthcare facilities and allow physicians to focus more of their efforts on combatting COVID-19.”
Garnett added: “At the same time, Lilly recognizes that for patients already enrolled in clinical trials, discontinuation would disrupt their treatment and potentially diminish the societal value of the research information to which they are contributing. Therefore, we will maintain ongoing studies, but with study-by-study consideration.”
Lilly said that study participants currently enrolled in Lilly clinical trials should continue following study protocols and are encouraged to speak with their physician if they have any concerns.
In a separate development, Lilly began offering drive-through testing for SARS-CoV-2, the virus that causes COVID-19, to Indianapolis area healthcare workers beginning Monday, March 23, 2020 as a service to the community and in an effort to protect healthcare providers during this epidemic.
Last week (March 18, 2020), the company reported that it is working with the Indiana State Department of Health to offer testing of COVID-19 samples acquired at local hospitals by using a specialized facility at Lilly Research Laboratories. Now, Lilly is expanding the service to the community by offering drive through-testing at Lilly’s Indianapolis headquarters. At this time (March 23, 2020), only active healthcare workers are eligible, and they must have a physician’s order requesting testing for COVID-19. The company says that there will be no charge for this service.
Source: Eli Lilly and Company (clinical trials) and Eli Lilly and Company (drive-through testing)
Gilead Sciences Requests FDA To Rescind Orphan-Drug Status for COVID-19 Drug Candidate
Gilead Sciences has asked the US Food and Drug Administration (FDA) to rescind the orphan-drug designation of remdesivir, its antiviral drug candidate being studied for the treatment of the novel coronavirus (COVID-19), and is waiving related benefits of this designation. The company has also provided updated information regarding access to remdesivir.
In early March (March 2020), Gilead sought and was subsequently granted an orphan-drug designation for the remdesivir as a potential treatment for COVID-19. Orphan-drug designation is granted by the FDA in situations where the disease affects fewer than 200,000 patients in the US. Orphan-drug designation qualifies the sponsor of the drug for various development incentives, including tax credits for qualified clinical testing, certain exemptions from prescription-drug user fees, and incentives for market exclusivity.
Gilead says it is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir without the orphan-drug designation. The company says that recent engagement with regulatory agencies has demonstrated that submissions and review relating to remdesivir for the treatment of COVID-19 are being expedited.
With regard to access to remdesivir, Gilead says it is working to assess the safety and efficacy of remdesivir as a potential treatment for COVID-19 through multiple ongoing clinical trials. The company says that enrollment in clinical trials is the primary way to access remdesivir to generate critical data that inform the appropriate use of this investigational medicine.
Gilead says it has been working with regulatory agencies to provide remdesivir to severely ill patients, who are unable to enroll in clinical trials and for whom no approved treatment options are effective, where feasible. To date, Gilead has provided emergency access to remdesivir for several hundred patients in the US, Europe and Japan.
“In recent weeks, there has been an exponential increase in compassionate-use requests for emergency access to remdesivir, related to the spread of COVID in Europe and the United States,” said Gilead Sciences in a company statement. “This increase has flooded an emergency- treatment access system that was set up for very limited access to investigational medicines and never intended for use in response to a pandemic.”
To streamline the emergency-access process, Gilead says it is currently in the process of transitioning from individual compassionate-use requests to expanded access programs. “This approach will both accelerate access to remdesivir for severely ill patients and enable the collection of data from all participating patients,” said the company in its statement. “These programs are currently under rapid development in conjunction with national regulatory authorities worldwide and may vary by region based on local laws and regulations.”
During this transition period, Gilead says it is unable to accept new individual compassionate- use requests due to an overwhelming demand over the last several days. “The company is focused on processing previously approved requests and anticipates the expanded access programs will initiate in a similar expected timeframe that any new requests for compassionate use would have been processed,” said the company in its statement.
As an exception, compassionate-use requests may still be made for pregnant women and children less than 18 years of age with confirmed COVID-19 and severe manifestations of disease, said the company.
Source: Gilead Sciences (orphan-drug designation) and Gilead Sciences (access programs)
Roche Provides Update on Actions Relating to COVID-19
Roche has provided an update on the various actions the company is taking to address the COVID-19 pandemic.
Roche has confirmed (as of March 24, 2020), initiation of a randomized, double-blind, placebo-controlled Phase III clinical trial to evaluate the safety and efficacy of the company’s Actemra/RoActemra (tocilizumab), a drug to treat certain forms of arthritis, for treating severe pneumonia caused by the novel coronavirus (COVID-19). The study will evaluate Actemra/RoActemra plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care.
This is the first global study of Actemra/RoActemra in this setting. In addition to the Roche trial, Roche says it is following independently led clinical trials, on multiple medicines, including Actemra.
With the announcement of new clinical trials, and a potential increase in demand for Actemra, Roche says it is working to accelerate manufacturing capacity to maximize production of Actemra wherever possible with the goal of increasing available supply globally. The company says that while it is ensuring a coordinated, global overview of additional supply requests, provision of medicines is managed on a country level according to local rules and regulations and in collaboration with the authorities.
Roche also provided an update on the availability of its diagnostic test for COVID-19.
Roche says it is committed to delivering as many tests as possible within the limits of supply and delivering its coronavirus tests to areas where they can be immediately effective. The company says tests will be shipped from Roche’s production sites to locations where appropriate infrastructure is in place and testing can begin without delay.
At the current maximum production rate, Roche says it can supply millions of tests per month on the cobas 6800/8800 instruments and on the MagnaPure / Lightcycler solution.
Amgen Pledges $12.5 M To Support COVID-19 Relief Efforts
Amgen and the Amgen Foundation announced an initial commitment of up to $12.5 million to support US and global relief efforts to address critical needs in communities impacted by the COVID-19 pandemic. The funds will be used to support emergency response efforts in Amgen’s US and international communities, patient-focused organizations that are mounting their own response efforts, and international relief efforts by the non-profit relief organizations, Direct Relief and International Medical Corps. The Amgen Foundation will also match donations made by Amgen staff globally who wish to contribute their own funds to the relief efforts.
AstraZeneca To Donate 9 Million Face Masks for Healthcare Workers in COVID-19 Efforts; Provides Update on Screening and Drug-Development Efforts
AstraZeneca has provided updates on its efforts with regard to the novel coronavirus (COVID-19).
The company is donating nine million face masks to support healthcare workers globally as they respond to the COVID-19 global pandemic. The company has partnered with the World Economic Forum’s COVID Action Platform, which was created with the support of the World Health Organization, to identify countries in greatest need. Italy will receive the first shipments this week (as announced March 24, 2020) with other countries to follow.
In addition to these donations, AstraZeneca is accelerating the development of its diagnostic- testing capabilities to scale up screening and is also working in partnership with governments on existing screening programs to supplement testing. To help ensure the continued supply of its medicines to patients, AstraZeneca says it will screen employees across its manufacturing and supply network.
AstraZeneca’s research and development (R&D) teams have also been working to identify monoclonal antibodies to progress toward clinical-trial evaluation as a treatment to prevent COVID-19. More than 50 virology, immunology, respiratory, and protein-engineering experts across research, clinical, regulatory, and manufacturing are working on developing a treatment to minimize the global impact of the disease.