1. Scrip
  2. >>New Products

US FDA Sends Amgen/UCB Evenity Back With BRIDGE Request

 
• By Alexandra Shimmings

The US FDA has surprised no-one with a Complete Response Letter for Amgen and UCB's novel osteoporosis treatment Evenity but, with luck, analysts say the product might still reach the market in 2018-19 and garner sales over £500m.

Boots
BRIDGE Over Evenity's Troubled Waters • Source: Shutterstock

Amgen Inc./UCB SA's investigational therapy for osteoporosis Evenity (romosozumab) could still bring in sales of more than half a billion dollars despite delays to market and concerns over its adverse event profile, say analysts as the product received a Complete Response Letter from the US FDA.

Hopes for a swift approval for the first-in-class sclerostin inhibitor died when a cardiovascular safety signal overshadowed positive efficacy data...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from New Products

Pipeline Watch: ASCO Dominates Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Santen Sees Potential In Myopia Market After Ryjunea Approval

 
• By Kevin Grogan

The low-dose atropine eye drop slowed the progression of pediatric myopia by 30%.

Atai/Beckley Merger Comes At A Transformative Time For Psychedelics

 
• By Kevin Grogan

All eyes are on the upcoming readout of BPL-003 for treatment-resistant depression.

Stock Watch: How GSK’s Nucala Info Drip Helped Share Price

 
• By Andy Smith

The information flow in the months before the approval of GSK’s Nucala in COPD provides an interesting case study, and brings to mind the cautionary tale of Alnylam’s Onpattro.

More from Scrip

In Brief: PolyPid’s D-PLEX100 Aces Phase III Trial, US Partner, Submission Eyed

 
• By Sushmita Panda

PolyPid's D-PLEX100 meets Phase III endpoints this time around, significantly reducing surgical point infections in abdominal colorectal surgery, and is set for a US approval submission early next year.

Insmed’s PAH Data Indicate Potential To Surpass Established Therapies

 
• By Joseph Haas

Insmed’s inhaled treprostinil exceeded goals for reducing pulmonary vascular resistance and improving six-minute walk test distance in Phase IIb data.

NewAmsterdam’s CETP Inhibitor Improves Alzheimer’s Biomarkers

 
• By Mandy Jackson

Data from the BROADWAY trial testing LDL-C reduction in adults with ASCVD showed that obicetrapib improved Alzheimer’s disease biomarkers, including tau and amyloid. Analysts think the data could differentiate obicetrapib against competitors in the cholesterol market.