Sarepta Therapeutics has provided the community with an update addressing questions from the community regarding COVID-19, including updates on current clinical trials and accessing approved therapies.
Read Sarepta’s Update
March 19, 2020
Dear Duchenne and Limb-girdle Communities,
These are unprecedented times and the novel coronavirus (COVID-19) has certainly reinforced that we are one global community. Sarepta employees are thinking of the individuals and families that have been impacted directly by this pandemic, as well as the families that are drawing from their wells of resilience and problem solving at increasing levels daily.
Advocacy groups have reached out to us to share key questions from the community, and we hope to address some of these questions here. This is a rapidly evolving situation and we cannot know the full extent of the impact; however, the Company will continue to monitor the situation, assess the potential impact, and do everything possible to meet the needs of the Duchenne and Limb-girdle communities.
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. *
*This information was updated on March 20, 2020 to accurately reflect updated CDC guidance.
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.
We appreciate the insights that have been shared with us by clinical trial sites and Advocacy groups. During a time of much ambiguity, we assure you that Sarepta remains steadfast in our focus and commitment to advancing and delivering innovative therapies for the Duchenne and Limb-girdle communities. We wish you all strength, health and safety through this difficult time.
The Sarepta Patient Affairs team