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

Insmed’s Amikacin Gains US FDA Panel Nod For Refractory Lung Disease

Executive Summary

But advisory committee recommends against sponsor's broader indication that would include first-line use in adults with nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex; panel narrowly endorses surrogate endpoint of sputum culture conversion.

You may also be interested in...



Mycobacterial Disease Drug Development Needs Validated Clinical Outcome Assessment

Experts at US FDA meeting debate tweaking components of existing measures to focus on symptoms – such as cough, fatigue and dyspnea – that are most bothersome to patients with the nontuberculous form of the disease.

LPAD As An Afterthought? Insmed’s Arikayce Reaches US Market Thanks To Limited Population Pathway

Amikacin liposome inhalation suspension for the treatment of Mycobacterium avium complex lung disease is first antimicrobial approved under 21st Century Cures Act pathway; LPAD designation request appears to have occurred after an advisory committee recommended approval for more limited population than requested by Insmed.

Arikayce’s Limited Population, Black Box Warning Won’t Limit Launch, Insmed Says

Because it will be initially targeting specialists and a very sick population, the biotech thinks Arikayce will get early usage in its narrowly defined lung infection indication.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS123634

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