FDA Approves Dose of MS Therapy Glatopa That Is Twice as Large as Current One

The U.S. Food and Drug Administration has approved a new dose of Sandoz’s multiple sclerosis therapy Glatopa (glatiramer acetate injection) that is twice as large as the currently authorized one.

Regulators’ approval of the 40 mg/mL applies to people with relapsing forms of MS. A mg/mL designation refers to the concentration of a substance in a liquid. In this case, it is 40 milligrams per milliliter of liquid.

Relapsing MS includes both relapsing-remitting MS, or RRMS, and secondary progressive MS, or SPMS, with relapses. SPMS is a worse disease phase that often follows RRMS.

Glatopa 40 mg/mL is a generic version of Teva’s Copaxone (glatiramer acetate injection, which the FDA approved in 1996. The drug was designed to be given three times a week.

Like Copaxone, Glatopa is an immunomodulatory injectable drug. It is made up of four amino acids found in the myelin sheath that protects nerve cell fibers — L-glutamic acid, L-alanine, L-tyrosine, and L-lysine. Glatopa reduces the frequency of MS relapses, studies have shown.

MS is an autoimmune disease, or one in which the body’s immune system attacks health tissue instead of invaders.

Scientists have yet to obtain a full understanding of how Glatopa works. But they believe it increases the number of the body’s regulatory T-cells, which in turns reduces the levels of the T-cells responsible for damaging the myelin sheath.

Scientists also believe that Glatopa boosts the activity of neurotrophic factors — molecules that help grow and maintain nerve cells.

Novartis’s Sandoz unit and Momenta Pharmaceuticals collaborated on the development of Glatopa. The approval of the new dose comes three years after the lower dose was authorized in 2015.

Patients can expect the same support services for Glatopa 40 mg/mL as they are receiving for Glatopa 20 mg/mL, the developers said.

“The approval and launch of Glatopa 40 mg/mL reinforces our leadership in delivering complex, differentiated generic products,” Richard Francis, the chief executive officer of Sandoz, said in a press release. “We look forward to bringing this product to patients and healthcare professionals and providing a full range of patient support services for Glatopa through GlatopaCare.”

Sandoz will offer a zero-dollar co-pay support program to qualified Glatopa 40 mg/mL patients in the United States. The program is called Sandoz GlatopaCare.

To help increase patients’ confidence that they can administer the injections, they will receive personalized injection training. They will also have 24-hour access to specialized nurses who can answer questions and help a patient get to know the company’s Starter Kit. The kit includes the Glatopaject injection device, which can be used with both 20 mg/mL and 40 mg/mL prefilled syringes.