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

Roche/GSK delay Boniva launch

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Launch of Roche/GlaxoSmithKline's osteoporosis agent Boniva (formerly Bonviva) will await approval of a less frequent dosing regimen. Ibandronate was approved May 16 as a once-daily 2.5 mg tab. "for the treatment and prevention of osteoporosis in postmenopausal women." Roche says the "submission will be supplemented at the earliest possible opportunity, following the completion of ongoing Phase III clinical trials." Merck's Fosamax (alendronate) and Procter & Gamble's Actonel (risedronate) are both available as once-weekly regimens. Boniva approval was based on studies in women with postmenopausal osteoporosis demonstrating reductions in the incidence of new vertebral and non-vertebral fractures and improvement in bone mineral density...

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS002279

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