Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Pfizer’s Vyndaqel Splits Advisory Committee; Now It Must Move FDA

This article was originally published in The Pink Sheet Daily

Executive Summary

In mirror-image votes, FDA’s Peripheral and Central Nervous System Drugs Advisory Committee says that there is substantial evidence for surrogate endpoints but not for clinical endpoints for the drug to treat familial amyloid polyneuropathy.

You may also be interested in...

Genzyme Lemtrada’s Momentum Halts With FDA “Refuse-To File” Letter

The company says a data formatting issue was the reason FDA declined to accept the supplemental application for alemtuzumab for relapsing multiple sclerosis.

Regulatory News, In Brief

CDC panel recommends combined regimen of Pfizer’s Prevnar 13 and Merck’s Pneumovax 23 in immunocompromised adults; FDA issues “complete response” letters and completes review of compounded hydroxyprogesterone.

When Is A Single Pivotal Trial “Robust” Enough? FDA’s Katz Offers Examples That Could Spell Trouble For Pfizer’s Vyndaqel

The single pivotal trial of Pfizer’s Vyndaqel couldn’t offer p-values of less than 0.01, nor substantial evidence from multiple sites, which could spell trouble for the new drug application.

Related Content


Related Companies

Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts