Sarepta continues to provide an uninterrupted supply of its therapies to patients and is working to do everything reasonably possible to minimize disruption to patients and meet their needs during this uncertain time. This page is intended as a resource to gather relevant links and information in one place.
It is critically important for patients and caregivers to contact your physician with specific questions and to stay up to date on your local health authority’s updated guidance.
Addressing your questions about COVID-19 vaccination and gene therapy
Sarepta has received many questions related to COVID-19 vaccines and gene therapy. Here, we provide current answers to some of these frequently asked community questions.
Questions about clinical trials
How will Sarepta deal with challenges to clinical trial data collection?
Sarepta is closely monitoring our studies and working to mitigate disruption and delay in both dosing or follow-up visits. We are working in accordance with guidance issued by regulatory bodies, such as US FDA and UK MHRA, who have provided direction and flexibility on clinical trial conduct during the pandemic. Sarepta is working closely with each site to adhere to this guidance to minimize risks to trial integrity and, most importantly, ensure that patient safety remains our top priority. We are evaluating options such as where we can adapt trial protocols to allow for virtual interactions and reduce risk to patients, while remaining fully compliant with Good Clinical Practice, and continuing to advance these important investigational treatments.
Does Sarepta have enough supply for current trials?
Sarepta continues to provide an uninterrupted supply of its therapies to patients and the Company has activated business continuity plans while taking steps to minimize disruption to patients.
What do I do if my clinical trial site closes?
Individuals involved in clinical trials are encouraged to keep in contact with their clinical trial sites to discuss any issues that may cause an interruption in the trial experience. We are quickly working to develop alternate methods of visit conduct where possible. These changes are being communicated to your clinical trial investigator.
What about home health care for clinical trials, will that continue?
We have recommended to investigators that patients supported by home health care be allowed to continue through that process. At this time, our home health vendors have informed us that they are still able to support the patients in our trials and will continue their visits and referral activities as planned. We are also working to expand access to home health services in trials where and when possible.
What about Sarepta’s trials that are due to start in 2020?
Sarepta will update the community about clinical trials as they start, and information may be found on clinicaltrials.gov.
Questions about accessing approved therapies in the United States
Does Sarepta have enough supply to provide patients that are on therapy?
Sarepta continues to provide an uninterrupted supply of its therapies to patients and the Company has activated plans to ensure business continuity while taking steps to minimize disruption.
What do I do if the clinic closes where my prescribed therapy is administered?
SareptAssist will work with families and Clinicians who wish to adopt home health care services for their patients. Please share updates about cancelled appointments with your SareptAssist Case Manager, especially if your appointment was going to include an assessment for reauthorization or if there is any other ongoing matter with your insurance company. SareptAssist Case Managers will help discuss circumstances and share information about approaches that may be taken.
Is it safe to have a home infusion nurse in my home?
Your safety is our first concern. Home Infusion providers have Infectious Disease Prevention Plans which include hand-washing hygiene and use of personal protective equipment (PPE) following guidance issued by the CDC. Please feel empowered to call your SareptAssist Case Managers or your Home Infusion Pharmacy to discuss precautions implemented by your provider.*
What if I have more questions about accessing the therapy that has been prescribed to me?
People taking Sarepta therapies are encouraged to work closely with their physicians and can also call SareptAssist (1-888-727-3782) with questions related to therapy.
Sarepta Contact Information:
|+1-888-727-3782||SareptAssist, available for patients in the U.S. taking an approved Sarepta therapy|
|For participants in Sarepta-sponsored clinical trials, Sarepta is working closely with site teams to mitigate disruptions caused by COVID-19 and encourages patients to contact their site team to understand the status of any upcoming visits. Sarepta is committed to helping patients navigate disruptions in trial participation and can be reached through this email and phone number for questions or concerns during this uncertain time.|
|[email protected]||Any additional patient, family, or caregiver questions|
Community Resources and Support
General Guidance and Statistics on the COVID-19 Pandemic
U.S. Centers for Disease Control and Prevention (CDC)
U.S. Federal Emergency Management Agency (FEMA)
World Health Organization (WHO)
For additional information on how Sarepta is working to support patients, providers, employees and communities, read our statement .