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FDA Gives Early OK to Alnylam Rare Disease Drug

By November 21, 2019No Comments

Alnylam Pharmaceuticals is well on its way to a goal of releasing a new drug each year through 2022, after receiving FDA approval Wednesday for a new gene-silencing treatment.

The FDA has approved Alnylam’s (Nasdaq: ALNY) new product Givlaari, which silences the gene behind a rare metabolic disease. The decision came more than two months ahead of the agency’s original Feb. 4, 2020 deadline.

The drug will cost approximately $575,000 annually.

Alnylam became the first drugmaker last year to receive FDA approval for these types of treatments, also known as RNA interference or RNAi drugs. Givlaari, which was previously known as givosiran, is the company’s second such product. Company executives previously told the Business Journal they expect to submit at least three more drugs in the next three years.