Dear SMA Community,
Like many organizations across the United States and around the world, AveXis is closely monitoring the coronavirus disease (COVID-19) and its impact on patients, the SMA community, healthcare providers, and our employees and partners. We know that life with a rare genetic disease can bring significant challenges, and we want to be as supportive as possible, particularly during this unprecedented time. We are dedicated to the SMA community, and our patients and their families are the motivation for everything we do.
For the safety of all, we are following the Centers for Disease Control and Prevention (CDC) recommendation for social distancing. We will provide support to patients, the SMA community, and healthcare providers via phone, text, or email for the foreseeable future. AveXis will continue to monitor the situation, and if virtual support is necessary for an extended amount of time, we will let everyone know.
Additionally, other measures have been put in place to help ensure an uninterrupted supply of ZOLGENSMA® (onasemnogene abeparvovec-xioi) and to support patients who have been, or are preparing to be, infused with ZOLGENSMA.
Maintaining ZOLGENSMA supply
First and foremost, ZOLGENSMA is readily available. Our manufacturing team, as well as our partners, continue to work 24/7, and we do not anticipate a disruption in the supply chain at this time. We take seriously the need to urgently treat SMA as quickly as possible and remain committed to rapidly and safely delivering ZOLGENSMA to patients when prescribed by their physician.
Patients who have been infused or are preparing to be infused with ZOLGENSMA
Healthcare providers who have questions should contact AveXis medical information at [email protected].
Ongoing clinical studies
AveXis conducts clinical studies at investigational sites across the globe, including many here in the United States. The health, wellness, and safety of patients enrolled or who may enroll in one of our clinical studies, as well as the investigators and staff administering the studies, are vital.
AveXis is working with clinical trial site personnel to ensure the safety of patients in active studies occurring in the midst of the COVID-19 pandemic. AveXis is working closely with the investigators at the site to come up with personalized solutions for individual families, which may entail scheduling a call with the treating physician / PI to ascertain wellbeing of the patient and their family.
We do not expect clinical trial sites to close as a direct result of COVID-19. However, as it will be difficult or impossible to visit the site, alternative ways of ensuring your child’s safety are being considered. These include visits to more local clinics or hospitals for some of the same study tests, if possible, or home visits by the study doctor or nurse. If appropriate, you may be asked to record a home video of your child to demonstrate any developmental milestones.
We will continue to monitor the COVID-19 outbreak. Please be assured that our commitment to supporting people impacted by SMA will continue uninterrupted, and we stand with the SMA community during this unprecedented time. Read more about ZOLGENSMA here.
Sincerely,
The AveXis Team