Our Statement on COVID-19

Our Statement on COVID-19

July 29, 2020

At Agios, the health of our employees, our communities and the patients we serve is our top priority. As the global COVID-19 situation evolves, we continue to provide an uninterrupted supply of our commercial medicine TIBSOVO® (ivosidenib tablets). Based on inventory levels, we do not currently anticipate a shortage of TIBSOVO® even if extended COVID-19 disruptions were to persist. In addition, we have sufficient inventory of both TIBSOVO® and our investigational medicines to support our ongoing and planned clinical trials.

We have implemented precautionary measures, including suspending all international and domestic business travel and requiring the majority of our employees to work from home, to reduce the likelihood of exposure or transmitting the virus to others. While taking these precautions, we have activated business continuity plans to minimize disruptions to our business and continue to serve the patients who are counting on us.

We do not know the extent to which COVID-19 will continue to spread and impact society. We will continue to monitor the situation and evaluate the potential impact to our business.

Our Team and Communities

  • Most of our employees are working from home to reduce the likelihood of exposure or transmitting the virus to others. We have begun a deliberate, phased approach to returning to on-site work under a set of operating procedures designed to protect the health and wellbeing of our team and communities while considering the productivity of our employees.
    • To date, only employees who have critical on-site work – such as those who work in our labs – have returned to our Cambridge headquarters.
    • We have implemented many measures to ensure the safety of those who need to be on-site, including daily health screenings, requiring the use of masks, clear signage to ensure social distancing can be maintained, single occupancy restrooms, scheduling in-person work and providing support to enable employees to commute without using public transit.
    • In addition, as local regulations and institutions have allowed, some of our field team members have begun to interact with their customers in person again.
  • We have made these decisions based on a number considerations, including local and national public health guidelines, updated data on COVID-19 cases, employee input on their preferences and our desire to reduce risk for our employees and communities while continuing to advance our important work on behalf of patients.

TIBSOVO® Patients

  • Agios continues to supply TIBSOVO® to patients in the United States. Based on current inventory levels, we don’t anticipate interruptions in TIBSOVO® supply, and have accelerated manufacturing to further mitigate risk.
  • In addition, Agios’ international expanded access program (EAP) is ongoing and there have been no disruptions to supplying TIBSOVO through this program related to COVID-19.
  • TIBSOVO® can also be delivered directly to patients’ residences to ensure they can still receive their medication even if they are homebound for a prolonged period of time.
  • myAgios™ Patient Support Services is fully functional and remains available to help patients with access, reimbursement, and financial assistance for TIBSOVO®. Healthcare providers can enroll patients at myAgios.com/enroll.
  • Our medicines are manufactured and packaged in controlled facilities that are approved by the U.S. Food and Drug Administration (FDA), ensuring the medicines are protected against all contaminants including COVID-19.
  • If you have questions or concerns about your treatment plan, please consult with your doctor.
  • If you have questions or concerns related to TIBSOVO®, please feel free to reach out to us at 833-228-8474 or medinfo@agios.com.

Clinical Trial Patients and Investigators

  • Inventory of our investigational medicines is in place to support ongoing and planned global clinical trials.
  • Because hospitals globally shifted resources to treat patients with COVID-19 at the beginning of the pandemic, Agios is experiencing some delays in clinical program timelines based on anticipated challenges related to data collection, access to trial sites and patient enrollment.
  • In February, Agios established a clinical trial task force to ensure the safety of patients in its clinical trials and to support patients on a case-by-case basis to enable their continued participation in the studies. Where appropriate, Agios has instituted home visits, telemedicine approaches, the use of local laboratories and courier shipments of investigational medicines.
  • We are continuing to monitor each of our clinical trials and are taking measures to minimize disruption.
  • If you have any questions or concerns, please consult with the physicians at your clinical trial site.