"Breakthrough Therapy" Status Could Hasten Novartis Drug Review

The Food and Drug Administration has granted "breakthrough therapy" status for Novartis' (NYSE: NVS  ) BYM338 drug, the company announced today, which could hasten regulatory review.

The drug is designed to treat a rare form of a potentially life-threatening muscular deterioration disease called sporadic inclusion body myositis (sIBM), Novartis said in its statement. At this time, according to Novartis, there are no existing treatments for sIBM, the symptoms of which can include losing the ability to walk, loss of hand function, and difficulty in swallowing.

The Novartis treatment stimulates muscle growth. Patients who took it during midstage testing "substantially benefited" compared with those taking a placebo, the drugmaker said. Novartis plans to present results from the study in October at an American Neurological Association meeting.

BYM338 is the third drug this year that has received breakthrough therapy status from the FDA, Novartis said.

FDA breakthrough status "is intended to expedite the development and review of drugs for serious or life-threatening conditions," according to the FDA. Novartis said the breakthrough therapy status leads to more intensive FDA interaction and guidance for the drugmaker than simply a fast-track designation, which also is designed to speed up the approval of drugs that treat life-threatening diseases.

-- Material from The Associated Press was used in this report.

link


Read/Post Comments (0) | Recommend This Article (1)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 2602820, ~/Articles/ArticleHandler.aspx, 8/21/2014 8:07:30 AM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...

Today's Market

updated 10 hours ago Sponsored by:
DOW 16,979.13 59.54 0.35%
S&P 500 1,986.51 4.91 0.25%
NASD 4,526.48 0.00 0.00%

Create My Watchlist

Go to My Watchlist

You don't seem to be following any stocks yet!

Better investing starts with a watchlist. Now you can create a personalized watchlist and get immediate access to the personalized information you need to make successful investing decisions.

Data delayed up to 5 minutes

Related Tickers

8/20/2014 4:00 PM
NVS $88.60 Down -0.03 -0.03%
Novartis CAPS Rating: *****

Advertisement