FDA gives conditional approval for a drug to treat Alzheimer’s disease

The Alzheimer’s is a neurodegenerative disease that causes difficulty in remembering the recent events. So far there has been no treatment that would reverse its progression but with the help of medicines, some of the symptoms could be managed. But now there is some good news as the Food and Drug Administration has approved a drug while making it the first therapy for Alzheimer’s to be approved in about 20 years. But this is going to be a conditional approval.

But the statisticians at FDA had opposed the approval by the agency while arguing that there was not enough evidence that would prove that the treatment would work. The drug is known as Aduhlem and has been given a conditional approval earlier in June 2021. The company Biogen that makes the drug will have to conduct more clinical research to prove that the therapy actually helps the patients. Reports say that the controversial therapy costs a whopping $56,000 per year.

If the company fails to complete the study in the stipulated time or if the results show that the drug is not effective then the approval can be revoked. But such a possibility is rare. After the conditional approval, three members of the FDA advisory committee resigned as a protest on the approval of the drug. The critics have argued that the cost of the therapy is high and it needs expensive diagnostic procedures which can potentially overwhelm the healthcare system. In America, nearly 6 million people suffer from Alzheimer’s.

The experts who have opposed the decision argued that the primary statistical review does not recommend an approval of the drug. The decision by the statisticians was based on two major clinical trials out of which one had showed a positive result while the other had shown a negative result. People who were in favour of the approval said that the drug, Aduhelm reduces the level of amyloid plaque in the brain of a patient with Alzheimer’s.

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