The American Porphyria Foundation will continue to provide updates regarding access to FDA-approved treatments and ongoing clinical trials related to porphyria. If you are experiencing an issue with access to treatment, please contact the APF for support on 866-APF-3635 or firstname.lastname@example.org.
RECORDATI RARE DISEASES
Recordati Rare Diseases is committed to the well being of patients living with rare diseases. It’s our first priority to help protect the safety and lives of patients around the world. We will continue to endeavor maintaining a constant supply of our critical care products. Please contact us as needed using the enclosed link.
NOTE: TREATMENT OPTIONS FOR ACUTE PATIENTS WITH RECURRING ATTACKS DURING COVID-19 CRISIS:
Acute patients with recurring attacks may need an option for Panhematin treatment as Emergency Departments (ED) and Hospitals (for inpatient treatment) are overwhelmed with COVID-19 patients.
Treatment at an infusion center may be the next best option. To prepare for this:
At this time, there are no reported issues with clinical or commercial supply or distribution of Alnylam products. Please let us know at your earliest opportunity if you hear otherwise.
For US Patients on Commercial Therapies
Alnylam Assist® is available to take calls from patients and physician offices to provide support throughout the treatment process. If patients are unable to access their normal site of care, we encourage them to reach out and work with Alnylam Assist® for assistance. For patients with a home health benefit, Alnylam’s specialty pharmacy partners may be able to provide home health services through their experienced nursing staff. The best way to contact Alnylam Assist® is by calling 1-833-256-2748, 8am – 6pm ET.
For Patients Outside the US on Commercial Therapies
We recommend that patients call their treating physician or doctor’s office for guidance and to make alternative arrangements if needed.
Continuity of Care
With health systems prioritizing acute care associated with the COVID-19 pandemic, continuity of routine care is an ongoing concern. More and more, care centers are postponing visits and procedures. Patients may be uncomfortable or unable to go out for appointments. Many of you have issued guidance to your communities on this topic. Like you, we recommend that patients call their treating physician or doctor’s office for guidance and to make alternative arrangements if needed.
CLINUVEL is continuously reviewing its operations to assess ongoing supply of SCENESSE®. The synthetic peptide, afamelanotide, which is the active ingredient in SCENESSE®, is manufactured under current good manufacturing practice (GMP) conditions in the European Union and is supplied to a contract manufacturer under cold-chain transport in the USA. Other synthetic excipients of SCENESSE® are sourced within the United States. Quality control of the drug product entering the European Union involves further laboratory testing before formal release of the product and controlled distribution to hospitals treating adult patients with erythropoietic protoporphyria (EPP).
Based on the sourcing, manufacturing and controlled distribution in place for SCENESSE®, there are currently no consequences to CLINUVEL’s business operations within the European Economic Area or the United States which could be impacted by the COVID-19 outbreaks. The situation continues to be closely monitored.
CLINUVEL is cognisant of worldwide concern about the spread of the coronavirus and its impact on the health of the community,” CLINUVEL’s Chief Scientific Officer, Dennis Wright said. “As part of our global pharmacovigilance and quality management systems, we have a duty to reassure the medical community. We can provide comfort to patients, physicians, and other stakeholders that the supply of SCENESSE® to those in need is not impacted by the current coronavirus outbreak.”