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Copaxone

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Copaxone
IUPAC nameL-glutamic acid polymer with L-alanine, L-lysine and L-tyrosine
TradenameCopaxone, Glatopa, others
Drugs.comMonograph
MedlinePlusa603013
Licence USDailyMed
Pregnancy AUB1
Routes of administrationSubcutaneous injection
ATC prefixL03
ATC suffixAX13
CAS number147245-92-9
DrugBankDB00020
UNII5M691HL4BO
KEGGD02558
SynonymsGlatiramer acetate

Copaxone is the brand name for glatiramer acetate, a synthetic immunomodulator medication used in the treatment of relapsing forms of multiple sclerosis. It is a random polymer composed of four amino acids designed to mimic myelin basic protein, a key component of the nerve insulation targeted by the immune system in MS. Administered via subcutaneous injection, it is believed to shift the immune response from a pro-inflammatory to an anti-inflammatory state, reducing the frequency of clinical relapses.

Medical uses

Copaxone is indicated for the treatment of patients with relapsing-remitting multiple sclerosis, including those who have experienced a first clinical episode and have features consistent with MS. Clinical trials, such as those monitored by the Food and Drug Administration, have demonstrated its efficacy in reducing the annualized relapse rate. It is often compared to other disease-modifying therapies like interferon beta-1a and fingolimod in treatment guidelines. The medication is not a cure for MS but is used for long-term management to decrease disease activity as measured by tools like the Expanded Disability Status Scale.

Adverse effects

The most common adverse reactions are localized injection site reactions, including erythema, pain, and lipoatrophy. A systemic immediate post-injection reaction, characterized by flushing, chest pain, palpitations, anxiety, and dyspnea, may occur and typically resolves spontaneously within minutes. Other potential effects include vasodilation and lymphadenopathy. While generally considered to have a favorable safety profile compared to some immunosuppressants, ongoing pharmacovigilance is conducted by agencies like the European Medicines Agency.

Pharmacology

Glatiramer acetate is a mixture of synthetic polypeptides composed of L-glutamic acid, L-alanine, L-lysine, and L-tyrosine in a defined molar ratio. Its exact mechanism of action in multiple sclerosis is not fully elucidated but is thought to involve modulation of immune processes. It is believed to promote the differentiation of naive T cells into T-helper 2 cells that secrete anti-inflammatory cytokines, potentially inducing regulatory T cells that migrate to the central nervous system. The drug may also act as a decoy, binding to major histocompatibility complex molecules and competing with myelin antigens for T-cell receptor recognition.

History

Copaxone was discovered through research led by scientists including Michael Sela and Ruth Arnon at the Weizmann Institute of Science in Israel. Its development was based on work on experimental autoimmune encephalomyelitis, an animal model of MS. The drug was subsequently developed by the pharmaceutical company Teva Pharmaceutical Industries. It received approval from the Food and Drug Administration in 1996, becoming one of the first disease-modifying therapies available for relapsing-remitting MS. The expiration of its patent led to the introduction of generic versions, such as Glatopa marketed by Sandoz.

Society and culture

As a first-line therapy for MS for decades, Copaxone has been a significant product for Teva Pharmaceutical Industries, impacting the global pharmaceutical market. Its development story is frequently cited in discussions about neuroscience research and biotechnology innovation originating from Israel. The drug's requirement for daily or thrice-weekly injections has influenced patient support programs and discussions about treatment adherence in chronic diseases. The advent of its generic forms has been a subject of analysis within healthcare economics, affecting formularies for organizations like the National Health Service.

Category:Drugs