March 18, 2020 / 1:25 PM / 11 days ago

FDA urges virtual patient visits as coronavirus disrupts clinical trials

(Reuters) - The U.S. Food and Drug Administration on Wednesday recommended switching to virtual patient visits instead of in-person monitoring for clinical studies, as signs emerge that the rapid spread of the coronavirus outbreak is disrupting trials.

FILE PHOTO: A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed

U.S.-based Iveric bio Inc (ISEE.O) delayed enrolment in a trial of its eye disease drug on Wednesday, two days after Provention Bio (PRVB.O) paused a study of its diabetes drug but allowed trial patients to complete their course.

The companies said these measures were taken to ensure the safety of the patients being tested and the medical staff.

The FDA said the outbreak may impact clinical trials of medical products including drugs and devices, as travel limitations and other considerations cause protocol deviations.

Authorities around the world have locked down cities and curbed travel to battle the pandemic that has infected about 200,000 people and caused nearly 8,500 deaths worldwide.

The restrictions have begun to disrupt the global pharmaceutical industry, as companies cancel public meetings.

The influential Boston-based research group Institute for Clinical and Economic Review said on Wednesday it was postponing two public meetings to discuss therapies for sickle cell diseases and cystic fibrosis.

“Trials that are fully recruited and those involving the critically ill seem likely to go on without too much disruption,” UBS analyst Laura Sutcliffe said in a client note.

“The situation is less clear for other trials, and several companies told us it is too early to tell if there will be any impact.”

Drugmakers are already making the switch. Catalyst Pharmaceuticals Inc (CPRX.O) told Reuters in an e-mail that it was implementing a virtual approach with doctors and company representatives to ensure patients had continued access to its rare neuromuscular disorder drug Firdapse, and remained on track to report results from its ongoing late-stage trial in the second quarter.

The outbreak has also hindered new drug launches as physicians and patients practice social distancing to curb the spread of the virus.

Aimmune Therapeutics Inc (AIMT.O), which has also set up virtual meetings with physicians, on Monday warned of a muted launch of its peanut allergy therapy, a day after Amarin Corp (AMRN.O) suspended in-person interactions for its sales representatives until March 30.

The companies did not provide specific details on the impact of the outbreak on their financial results.

Reporting by Manas Mishra and Saumya Sibi Joseph in Bengaluru; Editing by Sriraj Kalluvila

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