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

Aegerion’s Lomitapide Gets Standard Review For Rare Genetic Cholesterol Disease

This article was originally published in The Pink Sheet Daily

Executive Summary

Aegerion is preparing for an advisory committee meeting after submitting its LDL-C lowering oral drug lomitapide to FDA for patients with homozygous familial hypercholesterolemia. The NDA was submitted ahead of that for Isis/Genzyme’s injectable competitor, mipomersen.

You may also be interested in...



Panel Review Of Aegerion’s Lomitapide May Lead To Evolution Of Cholesterol Drug Approval Standards

FDA will be using an upcoming advisory panel review of Aegerion Pharmaceuticals Inc.’s lomitapide to see if there is still support for traditional lipid endpoints in clinical trials of cholesterol drugs.

Was Enobia’s Sale A High Water Mark For Rare Disease Deals?

Alexion’s “hotly contested” purchase of Enobia last December didn’t get much attention, but it marked a watershed year for rare disease drug deals. Will high drug prices, skittish regulators and a gold-rush push by Big Pharma start to sour the sector?

Financings Of The Fortnight Ponders The Potential Of Mapping The Microbiome

Plus news on recent financial activity by Tesaro, Omeros, Neviah Genomics and Aegerion Pharmaceuticals.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS073841

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