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     129  0 Kommentare Acorda Therapeutics Announces Biopas Laboratories Submission to Regulatory Agencies in Six Latin American Countries for Approval of INBRIJA

    Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the submission of new regulatory filings for the approval of INBRIJA (levodopa inhalation powder) in six countries in Latin America by its partner Biopas Laboratories (Biopas). INBRIJA is indicated in the United States for the intermittent treatment of OFF episodes in adult patients with Parkinson's disease (PD) treated with carbidopa/levodopa.

    Biopas has submitted for marketing approval of INBRIJA in Argentina, Colombia, Costa Rica, Ecuador, Panama and Peru. It expects to submit additional regulatory filings for approval of INBRIJA in Chile in late 2023 and in Mexico and Brazil in 2024.

    “We are delighted that Biopas has submitted filings for the approval of INBRIJA in six countries in Latin America, with up to five approvals expected in 2024. This is an important step forward for those living with Parkinson’s in these countries,” said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. “Biopas is a leader in commercializing CNS therapies in Latin America, and we thank them for their commitment to ensuring further access to our important medication.”

    About INBRIJA

    INBRIJA is an inhaled prescription levodopa medicine used to treat the return of Parkinson’s symptoms (known as OFF episodes) in people with Parkinson’s disease who are treated with carbidopa/levodopa medicines. It does not replace the regular carbidopa/levodopa medicines. INBRIJA is not to be used by people with PD who take or have taken a nonselective monoamine oxidase inhibitor, such as phenelzine or tranylcypromine, within the last 2 weeks. The most commons side effects of INBRIJA are cough, upper respiratory tract infection, nausea and change in the color of saliva or spit.

    About Acorda Therapeutics

    Acorda Therapeutics develops therapies to restore function and improve the lives of people with neurological disorders. INBRIJA utilizes Acorda’s innovative ARCUS pulmonary delivery system, a technology platform designed to deliver medication through inhalation. Acorda also markets branded AMPYRA (dalfampridine) Extended Release Tablets, 10 mg.

    About Biopas Laboratories

    Biopas is a leading and differentiated Latin American Pharmaceutical company, focused on in-licensing, marketing, and selling cutting-edge specialty pharmaceutical products. Biopas offers best-in-class capabilities in sales, marketing, medical, support functions and provides integral services to support the launch and development of innovative products reducing complexity for its partners and unlocking sales opportunities. Biopas operates in more than 20 countries in the Latin American region including Mexico and Brazil through its fully owned subsidiaries. Biopas is a trusted partner of reputable multinational pharmaceutical companies, and has products in leading positions in CNS, Immunology, Rare Disease, Oncology, Gastroenterology and Dermatology.

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    Acorda Therapeutics Announces Biopas Laboratories Submission to Regulatory Agencies in Six Latin American Countries for Approval of INBRIJA Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the submission of new regulatory filings for the approval of INBRIJA (levodopa inhalation powder) in six countries in Latin America by its partner Biopas Laboratories (Biopas). INBRIJA is …

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