John Serio featured in Precision Medicine Quarterly

31 March 2023 | Applicable law: US | 2 minute read

John Serio was recently featured in the Precision Medicine Quarterly article "Biogen Must Prove Tofersen in Genetically Defined ALS, Establish New Surrogate Endpoint."

The U.S. Food and Drug Administration (FDA) has accepted a drug application from Biogen for a new drug to treat amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. Specifically, the drug treats superoxide dismutase 1 ALS (SOD1-ALS), which has an underlying genetic cause. Biogen's drug tofersen would be the first of its kind to treat this rare variation of the disease, and the FDA is using data from clinical trials and an open-label study extension to review its efficacy. As Biogen seeks accelerated approval from the FDA, the company hopes to use a new, untried surrogate endpoint.

Withers' intellectual property partner John Serio commented, "it’s not unusual for companies to submit data on novel surrogate endpoints in FDA applications, particularly for drugs against complex, incurable diseases like ALS, about which scientists are still learning." John's expertise in biotech and pharmaceutical intellectual property matters gives him specific insight into the process, "nearly half of drugs approved by the FDA use surrogate endpoints, many of them novel" he said.

"Typically, when a drugmaker intends to apply to the FDA with a surrogate endpoint, the company will reach out to the agency early in the drug development process to discuss the scientific rationale for using the surrogate endpoint and ensure that the agency will accept the data they produce in studies" John indicated. 

Click here to read the full article. 

This document (and any information accessed through links in this document) is provided for information purposes only and does not constitute legal advice. Professional legal advice should be obtained before taking or refraining from any action as a result of the contents of this document.


Join the club

We have lots more news and information that you'll find informative and useful. Let us know what you're interested in and we'll keep you up to date on the issues that matter to you.