Teva’s Copaxone receives EU green light for use in pregnant women

Teva has announced that its multiple sclerosis drug Copaxone has been approved for use in pregnant women by European regulators.

The company has received a positive outcome through Europe's variation procedure to remove the pregnancy contraindication from the European label for the 40 mg/ml dose of Copaxone, which is administered three times weekly.

The UK's Medicines and Healthcare Products Regulatory Agency granted this approval based on an analysis of prospective pregnancy cases with known outcome and confirmed exposure to Copaxone from Teva's glatiramer acetate pharmacovigilance database.

Recent analysis of Copaxone 20 mg/ml pregnancy data, based on more than 2,000 pregnancy cases, has also demonstrated the safety of the therapy for pregnant women. Generally, it is still preferable for women not to use any multiple sclerosis treatments during pregnancy, but individual circumstances often make this necessary.

Dr Rob Koremans, president and chief executive officer of Teva's global specialty medicines unit, said: "For those women who can't stop taking the medication, who were previously discouraged from having children, the removal is excellent news and further underlines the established safety, efficacy and tolerability profile of Copaxone.

An equivalent change was previously approved for Copaxone 20 mg/ml in December 2016.

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