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Apr 16, 2015 - FDA approves Glatopa(TM) as the first generic competitor to MS therapy Copaxone® 20mg

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April 16, 2015 18:26 CET

Sandoz receives FDA approval for GlatopaTM as the first generic competitor to MS therapy Copaxone® 20mg


      • Glatopa is the first FDA-approved, substitutable generic version of Copaxone®20mg, a treatment for relapsing forms of multiple sclerosis
      • Novartis and Sandoz are driving access to a full range of differentiated, high-quality MS therapeutic options, complemented by a full range of support services

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Holzkirchen, Germany, April 16, 2015 - Sandoz, a Novartis company, today announced the US approval of GlatopaTM, the first generic version of Teva's Copaxone® (glatiramer acetate injection) 20 mg/ml one-time-daily multiple sclerosis therapy.

"Sandoz, together with Momenta, is proud to be the first company to receive FDA approval for a substitutable generic version of this important therapy," said Peter Goldschmidt, President of Sandoz US. "The approval of Glatopa reinforces Sandoz leadership in complex, differentiated generic products and further demonstrates our commitment to offer patients and payors a full range of therapeutic options."

MS is a debilitating disease affecting about half a million individuals in the US alone; only half of those diagnosed are currently treated.[1]

Glatopa, developed in collaboration with Momenta and produced entirely in the US, 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.

Sandoz is the global leader in complex differentiated generics, which represent more than 40% of its global portfolio, and one of the top two global generics companies by net sales.

Fighting MS, together with other CNS disorders, is central to the Novartis mission, and Sandoz's Glatopa joins a broad MS portfolio including two approved therapies and one late-stage development compound.

Important Safety Information
Glatiramer acetate is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol.

Approximately 16% of glatiramer acetate patients vs. 4% of those on placebo experienced a constellation of symptoms immediately after injection that included at least 2 of the following: flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and urticaria. These symptoms generally have their onset several months after the initiation of treatment, although they may occur earlier, and a given patient may experience 1 or several episodes of these symptoms. Typically, the symptoms were transient and self-limited and did not require treatment; however, there have been reports of patients with similar symptoms who received emergency medical care.

Transient chest pain was noted in 13% of glatiramer acetate patients vs. 6% of placebo patients. While some episodes of chest pain occurred in the context of the immediate post-injection reaction described above, many did not. The temporal relationship of this chest pain to an injection was not always known. The pain was transient, often unassociated with other symptoms, and appeared to have no clinical sequelae. Some patients experienced more than 1 such episode, and episodes usually began at least 1 month after the initiation of treatment.

At injection sites, localized lipoatrophy and, rarely, injection site skin necrosis may occur. Lipoatrophy may occur at various times after treatment onset (sometimes after several months) and is thought to be permanent. There is no known therapy for lipoatrophy.

Because glatiramer acetate can modify immune response, it may interfere with immune functions. For example, treatment with glatiramer acetate may interfere with recognition of foreign antigens in a way that would undermine the body's tumor surveillance and its defenses against infection. There is no evidence that glatiramer acetate does this, but there has not been a systematic evaluation of this risk.

The most common adverse reactions with glatiramer acetate vs placebo were injection site reactions (ISRs), such as erythema (43% vs 10%); 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 adverse reactions leading to discontinuation of glatiramer acetate. ISRs, such as erythema, pain, pruritus, mass, edema, hypersensitivity, fibrosis, and atrophy, occurred at a higher rate with glatiramer acetate than placebo.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for glatiramer acetate.

Complete article found here

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