Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

BI’s Olodaterol Wants Novel Exercise Claims In COPD

This article was originally published in The Pink Sheet Daily

Executive Summary

Proposed claims for Striverdi Respimat include improved exercise tolerance and increased inspiratory capacity, but FDA has no clear regulatory pathway for them.

You may also be interested in...



Boehringer’s Novel Exercise Claims In COPD May Spur FDA Action To Clarify Requirements

Company was hoping for an exercise tolerability claim for olodaterol, but members of the Pulmonary-Allergy Drugs Advisory Committee questioned several aspects of the trials and suggested FDA issue guidance on the matter.

Boehringer’s Olodaterol Gains Advisory Committee Support, But May See Indication Clarified

FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 15-1 that efficacy and safety had been shown, but said the label should not imply it is a treatment for chronic bronchitis and emphysema, just airway obstruction in those conditions, as well as COPD.

Boehringer’s Olodaterol Will Have To Pass LABA Hurdles At January Advisory Committee

Boehringer Ingelheim’s long acting beta-adrenergic agonist for chronic obstructive pulmonary disease will have to overcome LABA class issues in asthma at an advisory committee in January. The drug is up first for single-agent approval, but it is meant to be half of a combination therapy with the blockbuster treatment Spiriva.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

ID1135947

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