Amgen's muscular disorder drug meets main goal in late-stage study
Adds background on company's drug uplinza in paragraphs 7-10
Sept 24 (Reuters) -Amgen AMGN.O said on Tuesday that its drug helped improve daily activities including chewing and swallowing in patients suffering from a rare muscle-weakening disease, meeting the main goal of a late-stage study.
The drug, inebilizumab, was tested in patients suffering from myasthenia gravis, which is caused by an abnormal immune reaction that weakens the muscles that control the eyes, mouth, throat and limbs.
Inebilizumab, also known as uplizna, belongs to a class of drugs that target a protein, called CD19, present on immune cells.
Myasthenia gravis is estimated to affect about 36,000 to 60,000 people in the United States, according to the Myasthenia Gravis Foundation of America.
Separately, the drugmaker also said its experimental drug, rocatinlimab, met the main goals and secondary goals in a late-stage study that tested it as a treatment for an inflammatory skin condition known as atopic dermatitis.
Shares of the drugmaker fell about 2% to $325 in extended trading.
Last year, the U.S. Food and Drug Administration approved Netherlands-based Argenx SE's ARGX.BR subcutaneous injection, Vyvgart Hytrulo, as a convenient treatment option for the muscle-weakening condition.
Argenx's drug, which uses the active ingredient efgartigimod, was first approved by the FDA in 2021 as an intravenous injection.
Uplizna is unlikely to meet the high bar set by Argenx's Vyvgart, but its once every 6-months dosing could be a potential differentiator if safety is clean, TD Cowen analyst Yaron Werber said in a note ahead of the results.
Uplizna - if approved for myasthenia gravis - will also compete with AstraZeneca's AZN.L Soliris, another intravenous treatment.
Reporting by Mariam Sunny, Bhanvi Satija and Puyaan Singh in Bengaluru; Editing by Alan Barona and Shailesh Kuber
Related Assets
Latest News
Disclaimer: The XM Group entities provide execution-only service and access to our Online Trading Facility, permitting a person to view and/or use the content available on or via the website, is not intended to change or expand on this, nor does it change or expand on this. Such access and use are always subject to: (i) Terms and Conditions; (ii) Risk Warnings; and (iii) Full Disclaimer. Such content is therefore provided as no more than general information. Particularly, please be aware that the contents of our Online Trading Facility are neither a solicitation, nor an offer to enter any transactions on the financial markets. Trading on any financial market involves a significant level of risk to your capital.
All material published on our Online Trading Facility is intended for educational/informational purposes only, and does not contain – nor should it be considered as containing – financial, investment tax or trading advice and recommendations; or a record of our trading prices; or an offer of, or solicitation for, a transaction in any financial instruments; or unsolicited financial promotions to you.
Any third-party content, as well as content prepared by XM, such as: opinions, news, research, analyses, prices and other information or links to third-party sites contained on this website are provided on an “as-is” basis, as general market commentary, and do not constitute investment advice. To the extent that any content is construed as investment research, you must note and accept that the content was not intended to and has not been prepared in accordance with legal requirements designed to promote the independence of investment research and as such, it would be considered as marketing communication under the relevant laws and regulations. Please ensure that you have read and understood our Notification on Non-Independent Investment. Research and Risk Warning concerning the foregoing information, which can be accessed here.
