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Sandoz Launches Glatopa (Glatiramer), First Generic Competitor to Copaxone

Treatment indicated for relapsing forms of MS

Sandoz has announced the U.S. launch of Glatopa, the first generic version of Teva’s Copaxone (glatiramer acetate injection) 20-mg/mL once-daily multiple sclerosis (MS) therapy.

MS is a debilitating disease affecting approximately 500,000 individuals in the U.S.; only half of those diagnosed are currently treated.

Glatopa is indicated for the treatment of patients with relapsing forms of MS, including those who have experienced a first clinical episode and have magnetic resonance imaging (MRI) features consistent with MS.

Four placebo-controlled trials provided evidence supporting the efficacy of glatiramer acetate injection (20 mg/mL/day) in patients with MS.

In study 1, 50 patients with relapsing/remitting MS (RRMS) received daily doses of either glatiramer acetate injection (20 mg/mL subcutaneously) or placebo. After 2 years of treatment, 56% of the glatiraminer group was relapse-free compared with 28% of the placebo group (P = 0.085). The mean relapse frequency was 0.6/2 years for glatiramer and 2.4/2 years for placebo (P = 0.005).

Study 2 enrolled 251 patients with RRMS (glatiramer acetate injection, n = 125; and placebo, n = 126). After 2 years of treatment, 34% of the glatiraminer group was relapse-free compared with 27% of the placebo group (P = 0.25). The mean number of relapses was 1.19/2 years for glatiramer and 1.68/2 years for placebo (P = 0.055).

In both of these studies, glatiramer acetate injection demonstrated a beneficial effect on the relapse rate, and the drug is considered to be effective in MS patients based on this evidence.

In Study 3, 481 patients who had recently (within 90 days) experienced an isolated demyelinating event and who had lesions typical of MS on brain MRI scans were randomly assigned to receive either glatiramer acetate injection (20 mg/mL; n = 243) or placebo (n = 238). The time to the development of a second exacerbation was significantly delayed in patients treated with glatiramer compared with placebo (hazard ratio, 0.55). Kaplan-Meier estimates of the percentage of patients developing a relapse within 36 months were 24.7% in the glatiramer group and 42.9% in the placebo group.

Study 4 included 239 patients with RRMS. The patients were treated with either glatiramer acetate injection (n = 119) or placebo (n = 120) in a double-blind manner for 9 months, during which they underwent monthly MRI scans. The study’s primary endpoint was the total cumulative number of T1 gadolinium-enhancing lesions during the 9 months of therapy. The median numbers of such lesions were 11 and 17 in the glatiramer and placebo groups, respectively (P = 0.003).

Because glatiramer acetate can modify the immune response, it may interfere with immune functions. For example, treatment with the drug may interfere with the recognition of foreign antigens in a way that would undermine the body’s tumor surveillance and its defenses against infection.

The most common adverse events (AEs) observed in clinical trials of glatiramer acetate versus placebo included injection-site reactions (ISRs), such as erythema (43% vs. 10%, respectively); vasodilatation (20% vs. 5%); rash (19% vs. 11%); dyspnea (14% vs. 4%); and chest pain (13% vs. 6%). ISRs were one of the most common AEs leading to the discontinuation of glatiramer acetate. ISRs, such as erythema, pain, pruritus, edema, hypersensitivity, fibrosis, and atrophy, occurred at higher rates with glatiramer acetate than with placebo.

Sources: Sandoz; June 18, 2015; and Glatopa Prescribing Information; March 2014.

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