BioMarin update - Impact of the COVID-19 pandemic
Update for European Achondroplasia Associations
8 April 2020
BioMarin is providing this statement to provide general information about the company's clinical development program for achondroplasia in the context of the COVID-19 (Coronavirus) pandemic.
"As more cases of COVID-19 are confirmed, we recognize the increased challenges and concerns faced by participants in the BioMarin clinical studies. The safety and well-being of study participants, healthcare providers, and our communities is paramount as the ongoing COVID-19 pandemic impacts the health and livelihoods of many worldwide.
Many regulatory bodies, health authorities, and government departments have now issued directives and guidance to help sponsors safely and appropriately manage clinical studies during this pandemic. BioMarin continues to conduct our studies according to this guidance. BioMarin plans regulatory submissions of Vosoritide in 3Q 2020 in both US and Europe. Those regulatory submissions will be reviewed by regulators over many months to allow them to evaluate Vosoritide’s safety and efficacy in order to determine whether it can be made available.
BioMarin is in regular contact with investigators and study site staff at sites in all countries and is providing guidance to local study teams regarding study conduct. We acknowledge and are extremely grateful for all study participants and staff for their contribution and commitment to this program, especially during this pandemic.
For more information: Individuals enrolled in any BioMarin clinical study should contact their trial site staff for the latest updates and to answer any specific questions they might have.
This is a rapidly evolving situation and all efforts are being made to continue the BioMarin clinical program while remaining acutely aware of the safety for all individuals. We are committed to partnering with the community to continually reassess, find solutions and provide necessary updates."
8 April 2020
BioMarin is providing this statement to provide general information about the company's clinical development program for achondroplasia in the context of the COVID-19 (Coronavirus) pandemic.
"As more cases of COVID-19 are confirmed, we recognize the increased challenges and concerns faced by participants in the BioMarin clinical studies. The safety and well-being of study participants, healthcare providers, and our communities is paramount as the ongoing COVID-19 pandemic impacts the health and livelihoods of many worldwide.
Many regulatory bodies, health authorities, and government departments have now issued directives and guidance to help sponsors safely and appropriately manage clinical studies during this pandemic. BioMarin continues to conduct our studies according to this guidance. BioMarin plans regulatory submissions of Vosoritide in 3Q 2020 in both US and Europe. Those regulatory submissions will be reviewed by regulators over many months to allow them to evaluate Vosoritide’s safety and efficacy in order to determine whether it can be made available.
BioMarin is in regular contact with investigators and study site staff at sites in all countries and is providing guidance to local study teams regarding study conduct. We acknowledge and are extremely grateful for all study participants and staff for their contribution and commitment to this program, especially during this pandemic.
For more information: Individuals enrolled in any BioMarin clinical study should contact their trial site staff for the latest updates and to answer any specific questions they might have.
This is a rapidly evolving situation and all efforts are being made to continue the BioMarin clinical program while remaining acutely aware of the safety for all individuals. We are committed to partnering with the community to continually reassess, find solutions and provide necessary updates."
