Teva Pharmaceutical Industries Ltd. announced that the US Food and Drug Administration (FDA) has accepted for review the company’s supplemental new drug application (sNDA) for Copaxone (glatiramer acetate injection) 40mg/ 1mL, a higher concentration dose of Copaxone that offers a less frequent three times a week dosing regimen administered subcutaneously for patients with relapsing-remitting multiple sclerosis (RRMS). Currently, the approved dose for Copaxone is 20 mg/ 1mL, which is a once a day subcutaneous injection.
"We are pleased that the US FDA has accepted for review our sNDA. If approved, Copaxone 40mg/ 1mL given three times weekly will offer patients and their physicians flexibility in choosing a dosing regimen that works best for them, built upon the proven efficacy and established safety track record that Copaxone offers," said Michael Hayden, MD, president of Global R&D and chief scientific officer, Teva Pharmaceuticals Industries Ltd. “With a strong heritage in MS research innovation, Teva continues to demonstrate its commitment to patients by developing new treatment options to benefit the RRMS community.”
Copaxone (glatiramer acetate injection) is indicated for the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis, including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis. The most common side effects of Copaxone are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain.
Copaxone is now approved in more than 50 countries worldwide, including the United States, Russia, Canada, Mexico, Australia, Israel, and all European countries.
Teva Pharmaceutical Industries Ltd. is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients.