Tuesday, May 9, 2017

FDA Approves ALS Drug

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FDA Approved | ALS Drug

On Friday, May 5th,  for the first time in 22 years, the FDA approved Radicava (edaravone) to treat patients with ALS, also known as Lou Gehrig’s disease.  The Centers for Disease Control and Prevention estimates that there are approximately 12,000 to 15,000 Americans who have this disease, which attacks and kills nerve cells that control voluntary muscles.  A year’s course of the medicine will cost about $145,000 before discounts.

Radicava is an intravenous infusion administered with an initial treatment cycle of daily dosing for 14 days followed by 14 days without drugs.  The treatment then follows with dosing on 10 of 14 days followed by another 14 days without drugs.    The efficacy for this treatment was proven in a six-month clinical trial in Japan.  At Week 24, individuals receiving the drug experienced less of a decline on a clinical assessment of their daily functioning than those who received the placebo -- the patient’s symptoms deteriorated more slowly.  

Radicava does have side effects.  The most common reactions are bruising, headaches and gait disturbance.  Other risks include hives, swelling, shortness of breath and allergic reactions to sodium bisulfate that may cause anaphylactic symptoms.

If you suffer from ALS, contact your doctor to find out if this new drug may benefit you.

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