Skip to NavigationSkip to content

FDA green lights Amgen and UCB's Evenity in postmenopausal osteoporosis patients

Published on 10/04/19 at 12:05pm

The FDA has decided to approve Amgen and UCB Pharma’s Evenity (romosozumab-aqqg) for the treatment of postmenopausal osteoporosis patients at high risk of fracture, it has been revealed.

According to the manufacturers, Evenity is the “first and only bone builder with a unique dual effect that both increases bone formation and to a lesser extent reduces bone resorption (or bone loss) to rapidly reduce the risk of fracture”. Data from two Phase 3 studies showed that use of Evenity led to “significant reduction of new vertebral (spine) fracture at 12 months compared to placebo”, a benefit which persisted through a second year in women who switched to denosumab following one year on Evenity, compared to those who switched to denosumab from placebo.

As an added benefit, Evenity also “significantly increased” bone mineral density at the lumbar spine, total hip and femoral neck compared to placebo after one year of use, and continued to increase through the second year in patients who switched to denosumab.

The approval was awarded with the caveat that a five-year observational feasibility study must be carried out to assess the cardiovascular safety of the drug in postmenopausal osteoporosis patients.

"One in two women will experience a fracture due to osteoporosis in her lifetime. These fractures can be devastating, with many leading to hospital stays and life-altering consequences,” commented Dr David M Reese, Executive Vice President of Research and Development at Amgen. “The FDA approval of Evenity represents an important therapeutic development for patients who need a medicine that can rapidly increase bone mineral density and help reduce the risk of future fractures within 12 months. Postmenopausal osteoporosis is a significant women's health issue that far too often gets overlooked. As a leader in bone health with more than 20 years of osteoporosis research experience, Amgen is as committed as ever to combatting this disease to help women at high risk for fracture reduce their risk of a first and subsequent fracture."

Osteoporosis affects around 10 million in the US alone, and the condition is responsible for an estimated two million fractures per year. Costs arising from the condition in the US are thought to reach $25.3 annually by 2025.

"Osteoporosis is a serious disease that is underdiagnosed and often goes untreated. In fact, approximately 80 percent of patients who have had one or more osteoporotic-related fractures are not being identified or treated," said Elizabeth Thompson, Chief Executive Officer at the National Osteoporosis Foundation. "This approval is great news for patients and physicians because it gives them another much needed treatment option to help reduce the risk of life changing fractures."

Dr Pascale Richetta, Head of Bone and Executive Vice President at UCB, added: "Women who experience a fracture due to osteoporosis are at significant risk for another fracture within one to two years; however, many of these patients are not diagnosed with osteoporosis as the underlying cause of fracture so they do not  receive the proper care, and as a result, may experience new fractures. We are excited Evenity is now approved in the US and that physicians will have a new treatment option for postmenopausal women with osteoporosis who are at high risk for fracture."

Matt Fellows


That is really nice to hear. thank you for the update and good luck. handwriting analysis

It is a great website.. The Design looks very good.. Keep working like that!. Bed Sheets Linen

Thanks for sharing the post.. parents are worlds best person in each lives of individual..they need or must succeed to sustain needs of the family. body danza

What a fantabulous post this has been. Never seen this kind of useful post. I am grateful to you and expect more number of posts like these. Thank you very much. kauai family photos

I found your this post while searching for some related information on blog search...Its a good post..keep posting and update the information

Hi! Thanks for the great information you havr provided! You have touched on crucuial points! awarness

Love what you're doing here guys, keep it up!.. appliance repair service

Your website is really cool and this is a great inspiring article. ultimate performance singapore

I recently found many useful information in your website especially this blog page. Among the lots of comments on your articles. Thanks for sharing. 美国大学开除

Thank you for the update, very nice site.. carpet cleaning el paso

thanks this is good blog. pet socks

Excellent information on your blog, thank you for taking the time to share with us. Amazing insight you have on this, it's nice to find a website that details so much information about different artists. laser comb

Great! It sounds good. Thanks for sharing.. moisture

thanks for the tips and information..i really appreciate it.. custom name necklaces

Very interesting blog. Alot of blogs I see these days don't really provide anything that I'm interested in, but I'm most definately interested in this one. Just thought that I would post and let you know. Zahnarzt Luzern

thanks for this usefull article, waiting for this article like this again. Zahnimplantat Bern

Thanks for posting this info. I just want to let you know that I just check out your site and I find it very interesting and informative. I can't wait to read lots of your posts. ออกแบบเว็บไซต์

I haven’t any word to appreciate this post.....Really i am impressed from this post....the person who create this post it was a great human..thanks for shared this with us. depression therapy portland maine

Very nice article, I enjoyed reading your post, very nice share, I want to twit this to my followers. Thanks!. Kanye West

Interesting topic for a blog. I have been searching the Internet for fun and came upon your website. Fabulous post. Thanks a ton for sharing your knowledge! It is great to see that some people still put in an effort into managing their websites. I'll be sure to check back again real soon. Medicare Plan F

I am very happy to discover your post as it will become on top in my collection of favorite blogs to visit. Cultural tour India

This type of message always inspiring and I prefer to read quality content, so happy to find good place to many here in the post, the writing is just great, thanks for the post. MMA News

This is my first time visit here. From the tons of comments on your articles,I guess I am not only one having all the enjoyment right here! App Design

This type of message always inspiring and I prefer to read quality content, so happy to find good place to many here in the post, the writing is just great, thanks for the post. photo editing tampa

Thanks for the nice blog. It was very useful for me. I'm happy I found this blog. Thank you for sharing with us,I too always learn something new from your post. pcb design

Thanks for sharing this information. I really like your blog post very much. You have really shared a informative and interesting blog post with people.. Inventory Lending

Nice blog and absolutely outstanding. You can do something much better but i still say this perfect.Keep trying for the best. Limos of Denver

I just want to let you know that I just check out your site and I find it very interesting and informative.. divorce Chelmsford

Superbly written article, if only all bloggers offered the same content as you, the internet would be a far better place.. Houston Vending Machine Services

Ich habe diesen Beitrag gelesen und ihn gut und informativ erhalten. online casino wie sunmaker

Must have online shopping store of Health, Fitness, Beauty, Fashion, Kitchen, Clothing, Fashion, Pet, Garden, Phones, Car accessories, online shopping store health pet fashion.

Thank you for such a well written article. It’s full of insightful information and entertaining descriptions. Your point of view is the best among many. roadrunner email

This is a smart blog. I mean it. You have so much knowledge about this issue, and so much passion. You also know how to make people rally behind it, obviously from the responses. mylowes

I read a article under the same title some time ago, but this articles quality is much, much better. How you do this.. company income tax

Thanks for this article very helpful. thanks.

Good artcile, but it would be better if in future you can share more about this subject. Keep posting. time warner cable webmail

This is such a great resource that you are providing and you give it away for free. I love seeing blog that understand the value. Im glad to have found this post as its such an interesting one! I am always on the lookout for quality posts and articles so i suppose im lucky to have found this! I hope you will be adding more in the future... Judi Slot

I appreciate everything you have added to my knowledge base.Admiring the time and effort you put into your blog and detailed information you offer.Thanks. CITY Immobilienmakler Hannover

Thank you for some other informative blog. Where else could I get that type of information written in such an ideal means? I have a mission that I’m just now working on, and I have been at the look out for such information. energy reduction products phoenix

Thank you very much for the sharing! COOL.. komplex túlméretes szállítás

Hello I am so delighted I located your blog, I really located you by mistake, while I was watching on google for something else, Anyways I am here now and could just like to say thank for a tremendous post and a all round entertaining website. Please do keep up the great work.

howdy, your websites are really good. I appreciate your work. how to order do follow backlinks

Thanks for this article very helpful. thanks. in sweden

Very nice article, I enjoyed reading your post, very nice share, I want to twit this to my followers. Thanks!. cpt-frigid

Its a great pleasure reading your post.Its full of information I am looking for and I love to post a comment that "The content of your post is awesome" Great work. Enchanted Florist

I admire this article for the well-researched content and excellent wording. I got so involved in this material that I couldn’t stop reading. I am impressed with your work and skill. Thank you so much. custom embroidered patches

This article is an appealing wealth of informative data that is interesting and well-written. I commend your hard work on this and thank you for this information. You’ve got what it takes to get attention. armadillo removal

This article gives the light in which we can observe the reality. This is very nice one and gives indepth information. Thanks for this nice article. GardeningBlog

Nice blog and absolutely outstanding. You can do something much better but i still say this perfect.Keep trying for the best.

Thanks for sharing this useful info.. showbox for android

Mission Statement is a leading portal for the pharmaceutical industry, providing industry professionals with pharma news, pharma events, pharma service company listings and pharma jobs,
Site content is produced by our editorial team exclusively for and our industry newspaper Pharmafocus. Service company profiles and listings are taken from our pharmaceutical industry directory, Pharmafile, and presented in a unique Find and Compare format to ensure the most relevant matches