Accord Healthcare Adds Generic Drug Approved for the Treatment of Relapsing MS

Immunomodulatory agent Teriflunomide has been added to Accord's pharmaceutical portfolio

DURHAM, N.C., March 13, 2023 /PRNewswire/ -- Accord Healthcare, Inc., a leading generic pharmaceutical company, has added Teriflunomide to its portfolio of oral medications. The drug is formulated as a film-coated tablet. Accord's Teriflunomide is therapeutically equivalent to Sanofi Genzyme's Aubagio^® and is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. Accord's product is offered in a 14mg tablet and a 7mg tablet and is currently available to ship.

Teriflunomide is approved by the FDA for use as an immunomodulatory agent in patients 18 and older to decrease the frequency and severity of disease flare-ups, called relapses, to prevent new symptoms or a worsening of old symptoms related to the disease's neurologic impact.¹

"We're proud to add Teriflunomide to our portfolio. This is an important oral therapy for the millions of patients living with relapsing MS," said Accord Healthcare U.S. Vice President of Sales Jim Brown. "Generic medicine allows broad access to effective therapy, to help improve disease course and potentially slow progression of MS."

Important Safety Information: Teriflunomide can cause serious liver problems, including liver failure that may be life-threatening or require a liver transplant.² The risk of developing serious liver problems may be higher for those with liver problems or who take other medicines that also affect the liver. Teriflunomide is contraindicated for use in pregnant women and in females of reproductive potential who are not using effective contraception because of the potential for fetal harm.² Teriflunomide may stay in the blood for up to two years after taking it.²

Further information about safety, potential side effects, and full prescribing information can be found here at Accord Healthcare US.

Teriflunomide belongs to a class of drugs known as immunomodulatory agents or disease-modifying therapy. It works by inhibiting an enzyme essential to a biochemical pathway involved in the proliferation of lymphocytes, a type of white blood cell. Fewer activated lymphocytes reduces inflammation and immune reactivity to reduce relapse rates and to protect against brain volume loss resulting from inflammatory attacks on the nerve cells in the brain.^1,3

Teriflunomide was first approved by the FDA in 2012.¹

About Relapsing Forms of Multiple Sclerosis

About 2.8 million people live with multiple sclerosis globally, and most of them present with relapsing-remitting MS, which often starts in one's twenties or thirties. This form is diagnosed once a patient has had two or more attacks, or relapses, and is otherwise stable. Relapses are episodes of new or worsening symptoms. During a relapse, the immune system attacks the myelin sheath surrounding nerve fibers (demyelination) and ultimately the nerve fibers themselves. Symptoms related to nerve damage include double vision, balance problems, numbness, and fatigue. Active secondary progressive disease can occur as a second phase of relapsing-remitting MS.³

In relapsing forms of MS, symptoms vary by individual, often with no predictable pattern. Some patients have frequent relapses while others go years without a relapse.

About Accord Healthcare US

Accord Healthcare, a wholly owned subsidiary of Intas Pharmaceuticals, is a leading generic pharmaceutical company. Accord is committed to improving lives by increasing access to medicines while also providing novel solutions that enhance the pharmaceutical experience for both healthcare providers and patients. Accord Healthcare combines its advanced manufacturing technology with in-house research to produce highly complex, affordable, and essential medicines. Accord Healthcare's forward-thinking, innovative approach, and its resolve to help patients remains at the heart of everything they do. Accord is headquartered in Durham, North Carolina. The Intas network markets its products in 80 countries. To learn more, visit the Accord website.

References

¹ AUBAGIO^® (teriflunomide) tablets for oral administration. Food & Drug Administration. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202992s000lbl.pdf. Accessed Feb 2023.

² Teriflunomide, Prescribing Information, Accord Healthcare US. Available at https://www.accordhealthcare.us/products/#T. Accessed March 2023.

³ Miller, AE. An updated review of teriflunomide's use in multiple sclerosis. Neurodegenerative Disease Management. Vol. 11, No. 5. Published online Sep 2021. Available at: https://www.futuremedicine.com/doi/10.2217/nmt-2021-0014. Accessed Feb 2023.

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Kellyann Zuzulo
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SOURCE Accord Healthcare US