CARY, N.C., April 5, 2023 — Biologics by McKesson, an independent specialty pharmacy specializing in oncology and rare diseases, was selected by Reata Pharmaceuticals as the sole specialty pharmacy provider for SKYCLARYSTM (omaveloxolone), the first and only treatment for Friedreich’s ataxia (FA). SKYCLARYS was approved by the U.S. Food and Drug Administration (FDA) on Feb. 28, 2023, for the treatment of FA in adults and adolescents aged 16 years and older, along with a rare pediatric disease priority review voucher.
According to the National Institute of Neurological Disorders and Stroke, FA is a rare inherited disease that causes progressive damage to the nervous system, causing movement problems. The rate of progression varies, but within ten to twenty years after the appearance of the first symptoms, the person is usually confined to a wheelchair. FA could also shorten life expectancy, with heart disease being the most common cause of death.
“With the approval of SKYCLARYS, patients with Friedreich’s ataxia finally have a treatment available to them,” said Ela Lourido, vice president, Biopharma Services, Biologics by McKesson. “Therefore, we are honored to work with Reata Pharmaceuticals as the exclusive specialty pharmacy provider of SKYCLARYS, so patients battling FA can have access to a much-needed medication.”
Biologics by McKesson is committed to and recognized for its level of customer service as well as its innovative, high-touch approach. Putting patients first in all they do, each team includes pharmacists with in-depth knowledge of therapies, experienced nurses, and financial counselors who are familiar with various financial assistance programs and organizations that help patients. This deeply skilled care team works together to develop individualized care plans that address each patient’s unique clinical, financial, and emotional needs and streamlines communication back to the treating provider, enabling high-quality care and differentiated outcomes.
For more information about the symptoms, diagnosis, and treatment of Friedreich’s ataxia please click here. For more information about SKYCLARYS, including full prescribing information, please click here.
About Biologics by McKesson
Biologics by McKesson is an independent specialty pharmacy with more than 25 years of experience connecting patients to life-changing medications in oncology and other complex therapeutic areas. Built on the foundation of deep clinical expertise and a high-touch approach to patient care, Biologics delivers seamless access and personalized engagement, so patients get the most out of the care they receive. As a business within McKesson Corporation, Biologics harnesses unparalleled reach and connectivity across the healthcare system to connect the dots between payers, providers, and biopharma, so together, they can deliver better care and outcomes for every patient.
Important Safety Information
WARNINGS AND PRECAUTIONS
Elevation of Aminotransferases: Treatment with SKYCLARYS can cause an elevation in hepatic transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]). Monitor ALT, AST, and total bilirubin prior to initiation of SKYCLARYS, every month for the first 3 months of treatment, and periodically thereafter.
Elevation of B-Type Natriuretic Peptide: Treatment with SKYCLARYS can cause an increase in B-type natriuretic peptide (BNP), a marker of cardiac function. Elevations in BNP may indicate cardiac failure and should prompt an evaluation of cardiac function. Check BNP prior to initiation of SKYCLARYS. Monitor patients for the signs and symptoms of fluid overload.
Lipid Abnormalities: Treatment with SKYCLARYS can cause changes in cholesterol. Assess lipid parameters prior to initiation of SKYCLARYS and monitor periodically during treatment.
Adverse reactions reported in 10% or more of patients and greater than placebo were elevated liver enzymes (AST/ALT) (37%), headache (37%), nausea (33%), abdominal pain (29%), fatigue (24%), diarrhea (20%), musculoskeletal pain (20%), oropharyngeal pain (18%), influenza (16%), vomiting (16%), muscle spasms (14%), back pain (13%), decreased appetite (12%), rash (10%).
To report SUSPECTED ADVERSE REACTIONS, contact Reata Pharmaceuticals, Inc. at 1-800-314-3934 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.