Saturday, August 12, 2017
EDARAVONE- A NEW HOPE FOR PATIENTS SUFFERING FROM AMYOTROPHIC LATERAL SCLEROSIS (ALS)
Amyotrophic lateral sclerosis (ALS) is an uncommon degenerative disease of nervous system, mainly affecting the motor nerves. The common symptoms of ALS include weakness of arms and legs, difficulty in swallowing & speaking and breathing problem. The symptoms of ALS continue to get worse over time and most people die within 3-5 years after diagnosis, often due to respiratory failure.
Stephen Hawkings (suffering from ALS) AFP
There is no cure available for ALS. There is only one medication, RILUZOLE, which was approved for treating ALS in 1995. Riluzole can be used to slow down the deterioration in muscle strength. However, it has limited benefit in most patients. (In India, riluzole is offered free of cost to patients with ALS by Sun Pharmaceuticals).
Now, there is a new hope for patients with ALS. A new medicine, EDARAVONE INJECTION, has been approved by US FDA to treat patients with ALS.
What is basis of Edaravone efficacy?
A research was conducted in Japan on more than 100 patients suffering from ALS. Edaravone injections were given for a period of six months. After six months, patients who received edaravone had better functional status and better quality of life (as compared to those who did not receive edaravone).
Which patients with ALS would benefit from Edaravone injections?
Patients with ALS of less than two years duration, with mild disease severity, would benefit from edaravone. In addition, they should not suffer from any respiratory failure.
What is the treatment regimen?
Patients are given edaravone injection 60 mg per day as intravenous infusion (given over 60 minutes) for 14 days. Then there is a gap of 14 days. Edaravone injection is supplied as 30 mg/20 ml vials (in India). In US, it is usually supplied as 30 mg in 100 ml. So, two vials would be needed per day.
In second month, the injection is given on 10 out of 14 days. There is a gap of 14 days. This is continued for five months.
So, in total, patient receives 64 doses of edaravone injections (60 mg each time) over a period of six months.
How long is the treatment continued?
As of now, there is efficacy and safety data for six months, so, it should be continued for total of six months, as per the schedule mentioned above.
Is Edaravone treatment safe?
Yes, there are no serious adverse effects with edaravone. Minor side effects are similar to placebo.
Do we need to reduce the dose of Edaravone in patients with kidney or liver disease?
There is no need to reduce the dose in patients with renal or liver function impairment.
What is the cost of edaravone injections?
Each 30 mg vial costs about INR 400 (in India). So, the per day cost is about INR 800. The total cost of 64 days course of edaravone would be INR 51,200 (approximately 800 USD). Additional room rent, nursing charges, doctors fees, etc may be incurred.
How about Riluzole?
Riluzole tablets should be continued together with edaravone injections.
So, in summary, now we have a new drug for ALS, which is the first drug approved in 22 years for ALS after Riluzole.
DR SUDHIR KUMAR MD DM
Apollo Hospitals, Hyderabad