Investing
US FDA declines to approve AbbVie’s Parkinson’s disease therapy
© Reuters. FILE PHOTO: A sign stands outside a Abbvie facility in Cambridge, Massachusetts, U.S., May 20, 2021. REUTERS/Brian Snyder/File Photo
(Reuters) -AbbVie Inc said on Wednesday the U.S. Food and Drug Administration had declined to approve its Parkinson’s disease therapy for adults and had requested for more information on the device used to administer the treatment.
The therapy, ABBV-951, is a formulation of carbidopa-levodopa, the standard of care for the disease. It is administered subcutaneously, or under the skin, through an infusion pump.
The company’s application was based on data that showed the therapy significantly extended the time that patients did not observe involuntary movement, compared to orally administered carbidopa-levodopa.
Parkinson’s disease causes unintended or uncontrollable movements and is characterized by “off” periods in patients under therapy for a long period.
The U.S. health regulator has not sought additional efficacy and safety trials, the company said, adding it plans to resubmit the marketing application as soon as possible.
Analysts have forecast sales of $1.3 billion for AbbVie (NYSE:)’s therapy in 2028, according to Refinitiv data. The company’s shares were marginally lower in morning trade.
Read the full article here
-
Side Hustles6 days ago
3 Ways Data Can Drive Sustainable Decision-Making in Business
-
Passive Income6 days ago
5 Things Entrepreneurs Should Know Before Investing in Drones
-
Side Hustles6 days ago
NHTSA Investigates Tesla Full Self-Driving Feature
-
Investing6 days ago
Taiwan Semi to generate $110 billion in 2025 revenue: Needham By Investing.com
-
Investing6 days ago
Teen Brothers’ $1.2M Business Began as Facebook Side Hustle
-
Personal Finance6 days ago
A growing share of Gen Z adults don't think they'll retire: only 20% are saving for it
-
Passive Income5 days ago
This 2TB Data Storage Offer Is a Can’t-Miss at $89.97
-
Make Money6 days ago
American Workers Share Insights on Starting Salaries and Retirement