When the FDA’s Center for Drug Evaluation and Research approves new drugs, this expands patient treatment options and often makes healthcare advancements. So far this year, the FDA has approved 31 new drugs. New drug approvals may come in the form of entirely new products, or they may be for drugs similar to previously approved products.
While the process of getting a new pharmaceutical drug approved and onto the market is lengthy and expensive for manufacturers, this helps ensure that drugs are safe and effective for patients.
Here's one example from recent months. In May, the FDA approved a new drug for amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. ALS is a disease that affects nerve cells in the brain and spinal cord that control voluntary muscle movement. Currently, there is no cure for ALS. However, Radicava was the first new approval for treating ALS since 1995.
The Centers for Disease Control and Prevention estimates 12,000-15,000 Americans have ALS. This approval is a major milestone for ALS patients. Jonathan S. Katz, M.D. highlights this significance:
“For people with ALS and their families, having a new therapy which slows the decline of physical ability is incredibly significant. The approval of RADICAVA brings us into a new era of treatment by evolving how we manage this complex disease. This is an uplifting milestone for the ALS community especially since it’s been so long since we had anything new.”
To learn more, view the FDA's List on Novel Drug Approvals for 2017.
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