FDA Approves Lupin’s Generic Form of Tecfidera for MS Treatment
The therapy — dimethyl fumarate delayed-release capsules — is indicated for use in people with clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS). Similar to Tecfidera, by Biogen, Lupin’s generic equivalent will be available in two doses, 120 mg and 240 mg.
Lupin anticipates launching the treatment shortly in the U.S. market.
Tecfidera is an oral FDA-approved therapy for the treatment of adults with relapsing MS. It works by decreasing inflammation and preventing nerve damage that may cause the disease’s symptoms. Lupin’s newly approved generic equivalent is indicated for the same forms of the disease as the original therapy.
Headquartered in Mumbai, India, Lupin develops and commercializes branded and generic formulations in several markets, including the U.S. According to its website, Lupin has received more than 250 FDA approvals and markets a total of 180 generic products. Lupin is the third-largest pharmaceutical company in the U.S. based on the number of prescriptions, the company said.
The approval of generic products by the FDA follows a rigorous review process to ensure that the generic alternative contains the same active ingredient, strength, dosage form, and route of administration as the original brand-name product — in this case, Tecfidera.
Further, “all generic drugs approved by FDA have the same high quality, strength, purity, and stability as brand-name drugs,” the agency states.
While generics are equally safe and effective as the brand-name product, they usually are a lower-cost alternative.
According to the FDA’s website, nine out of 10 prescriptions filled are for generic drugs. “Increasing the availability of generic drugs helps to create competition in the marketplace, which then helps to make treatment more affordable and increases access to healthcare for more patients,” the agency says.
Tecfidera is thought to exert protective effects on the patient’s nervous system by activating a protein called nuclear-erythroid 2-related factor 2 (Nrf2). Nrf2 controls the activity of genes involved in oxidative stress — cell damage caused by high levels of oxygen reactive species — in the central nervous system, which is composed of the brain and spinal cord.
In clinical trials, Tecfidera showed efficacy in significantly reducing disease relapse rates in MS patients and in increasing the time to disease progression. The therapy is in general well-tolerated, with the most common side effects being flushing and stomach issues such as pain, indigestion, nausea, and vomiting. Such side effects usually decrease over time.