Dr. Karlawish on Biogen’s Alzheimer’s drug approval: ‘another study is needed’
- FDA approved Biogen's Alzheimer’s disease drug aducanumab on Monday.
- The medical community is divided on the grant of approval as evidence to approve the drug was not sufficient.
- Desperation should drive funding for Alzheimer’s research but not the interpretation of scientific evidence.
The Food and Drug Administration (FDA) approved Biogen Inc.’s (NASDAQ: BIIB) Alzheimer’s disease drug aducanumab on Monday. This makes the drug, to be marketed as Aduhelm, the first and only treatment to be granted approval to slow cognitive decline in people living with Alzheimer’s disease.
Shares of the biotechnology company surged more than 50% at one point yesterday after the announcement but traced back some gains to close up 38% higher at $395.85. Shares are down by around 4% in the morning trading today.
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The medical community, however, is divided on the grant of approval. Dr. Jason Karlawish, co-director of the University of Pennsylvania Medical Center, was on CNBC to discuss the newly approved drug.
Evidence to approve the drug was not sufficient
Calling into question the evidence used to approve the drug, Karlawish said:
“I think the evidence to approve the drug was not sufficient. Another study is needed to establish whether this drug in fact is effective.”
He further added that the FDA approved the drug on the condition that Biogen conduct another confirmatory clinical trial. But Karlawish thinks it will be a challenge to do the study when it is also available for clinical prescribing.
Will the doctor prescribe the drug?
On the question of whether Karlawish will prescribe Biogen’s drug to his patients, he said:
“I think I have to respect the principle of patient’s autonomy. So if the drug is available and after educating them about the uncertainties, risks and hassles, if someone wants to take it, I will write a prescription for it but I am not enthusiastic about it.”
He is optimistic about the coming future as there are a lot of other promising drugs in the pipeline. He thinks that aducanumab is not the drug on which he would pin his hopes on.
According to the Alzheimer’s Association, the number of Americans living with Alzheimer’s is expected to rise to around 13 million by 2050 from more than 6 million currently.
He understands the pressure on FDA to approve a drug for Alzheimer’s but believes:
“Desperation should drive funding for Alzheimer’s research. It should not drive the interpretation of scientific evidence.”