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

UsernamePublicRestriction

Rhone-Poulenc Rorer Rilutek (riluzole) for ALS approved Dec. 12, five-and-a-half months after NDA submission.

Executive Summary

RPR's RILUTEK FOR ALS WILL BE AVAILABLE WITHIN SIX WEEKS following FDA approval of the first treatment for patients with amyotrophic lateral sclerosis (Lou Gehrig's disease) on Dec. 12. Rhone-Poulenc Rorer said its "number one goal is to make the drug available to ALS patients as quickly as possible." Rilutek will be available within six weeks as a 50 mg tablet to be administered twice daily. The company will officially launch the product Jan. 10 when it will discuss availability and patient support services.

You may also be interested in...



US FDA Versus Its Own Precedents

The US FDA has shown astonishing flexibility in approving new drugs for neurodegenerative diseases based on efficacy evidence that falls well short of historical standards. Now the agency faces the delicate challenge of demonstrating that there are still some lines it will not cross.

ALS Drugs: A Long History Of Regulatory Twists At US FDA

The US FDA is set for two high-profile advisory committee meetings on potential ALS treatments before the end of 2022. Whatever the outcome, they will fit a pattern: when it comes to ALS treatments, there is very little about the regulatory process that feels routine.

Biogen Aducanumab BLA Plan Is In Line With US FDA Neurology Division Precedent

Biogen and Eisai's surprise decision to advance Alzheimer’s antibody despite mixed clinical results could follow a similar path as pioneering neurodegenerative therapies Xenazine and Rilutek, or more recent Parkinson’s drug Nourianz – or could end with suspended development, like Kyndrisa.

Latest Headlines
See All
UsernamePublicRestriction

Register

PS027399

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

Cancel