HOME >> MEDICINE >> NEWS
NOVANTRONE application for multiple sclerosis granted priority review by FDA

FDA review of NOVANTRONE data to be completed within six months

SEATTLE-Immunex Corporation (NASDAQ:IMNX) announced today that the U.S. Food and Drug Administration (FDA) has assigned priority review status to the new drug application (NDA) for NOVANTRONER (mitoxantrone for injection concentrate), indicating that the FDA will act on the application within six months of its date of submission. Immunex filed for expanded labeling for NOVANTRONE for the treatment of patients with secondary progressive multiple sclerosis (MS) on June 7, 1999.

"This is an important milestone in the development of NOVANTRONE as a potential treatment for people with secondary progressive MS," said Peggy V. Phillips, senior vice president, pharmaceutical development for Immunex. "We will continue to work closely with the FDA over the next six months as they evaluate these data."

The results of the pivotal NOVANTRONE Phase III study showed that NOVANTRONE had a statistically significant impact on reduction of relapse rate and delay in disability progression in patients with secondary progressive MS. Additional follow-up data presented at a recent international conference showed that one year after treatment was stopped, patients treated with NOVANTRONE continued to experience a reduction in their number of attacks, and a delay in their disability progression.

In the study, treatment with NOVANTRONE resulted in generally manageable side effects that were primarily mild to moderate. During the two-year trial, the most frequent side effects reported by patients treated in the 12 mg/m2 arm were nausea, alopecia (hair loss), upper respiratory tract infection, urinary tract infection, menstrual disorder, and transient neutropenia (a reduced number of white blood cells).

Multiple sclerosis is a chronic, debilitating disease of the central nervous system that, in its various stages, afflicts as many as 350,000 people in the Unit
'"/>

Contact: Lisa Crisera
criseral@immunex.com
206-389-4346
Immunex Corporation
19-Jul-1999


Page: 1 2

Related medicine news :

1. Immunex Files Supplemental NDA for NOVANTRONE
2. Considerable reductions in radiation exposure possible with 16-MDCT scanner on body applications
3. AstraZeneca submits regulatory application in Europe for use of Atacand(R) in heart failure
4. Roche files marketing application for Avastin with European health authorities
5. ENBREL application for early, active rheumatoid arthritis filed with the U.S. Food and Drug Administration
6. First mouse model for multiple system atrophy points to new treatment targets for brain diseases
7. Research suggests possible blood test for multiple sclerosis
8. Mayo Clinic researchers announce promising next generation treatments for multiple myeloma
9. Good fats decrease multiple heart disease risk factors
10. Swallowing multiple magnets poses danger to children
11. Sleep disorders often indicate multiple health conditions

Post Your Comments:
(Date:7/25/2014)... July 25, 2014 Ticket Down ... the board for the Guinness International Champions Cup match ... FC at Soldier Field on Sunday, July 27th. ... customer appreciation promo/coupon/offer code SOCCER-2014 for added savings. , ... for diehard soccer fans in North America. Countless international ...
(Date:7/25/2014)... Salt Lake City, UT (PRWEB) July 25, 2014 ... all basketball court surfaces for the recent Nike ... Place and the current United States Junior National ... Center through July 25. , The flooring for these ... courts totaling more than 300,000 square feet of playing ...
(Date:7/25/2014)... and MOSI officially announced a transformational partnership that will unite ... a difference in the Tampa Bay community. Florida Hospital presented ... support needed to keep the science center moving forward. ... Theatre from film to a state-of-the-art digital 3D projection system. ... state of Florida, and it is one of the first ...
(Date:7/25/2014)... July 25, 2014 AttorneyOne.com, a recognized authority ... information from the FDA on Ibuprofen and Oxcarbazepine Tablets ... one lot of Ibuprofen and one lot of Oxcarbazepine Tablets, ... to mislabeled packaging. Oxcarbazepine is used for the treatment of ... , The reason for the recall is that Lot #142588, ...
(Date:7/25/2014)... A new study of participants in the ... published today in Cancer , found evidence that men ... had an abnormal finding on a lung cancer screening test ... than did those who were screened and found to be ... the researchers. “We expected that participants with an abnormal finding ...
Breaking Medicine News(10 mins):Health News:Liverpool FC vs. Olympiacos FC Tickets Soldier Field: Ticket Down Slashes Ticket Prices for Guinness International Champions Cup in Chicago on Sunday, July 27th 2Health News:Sport Court Provides All Sports Flooring for Basketball Events in Chicago and Washington D.C. 2Health News:Florida Hospital Donates a Two Million Dollar Transformational Gift to the Museum of Science and Industry (MOSI) 2Health News:Florida Hospital Donates a Two Million Dollar Transformational Gift to the Museum of Science and Industry (MOSI) 3Health News:Florida Hospital Donates a Two Million Dollar Transformational Gift to the Museum of Science and Industry (MOSI) 4Health News:Ibuprofen and Oxcarbazepine Tablets Recalled: AttorneyOne Monitors and Keep Consumers Informed 2Health News:Full Explanation Reduces Seniors’ Worries about Lung Cancer Screening 2Health News:Full Explanation Reduces Seniors’ Worries about Lung Cancer Screening 3Health News:Full Explanation Reduces Seniors’ Worries about Lung Cancer Screening 4Health News:Full Explanation Reduces Seniors’ Worries about Lung Cancer Screening 5
(Date:7/25/2014)... 25, 2014 GrowBLOX Sciences, Inc. (OTCQB: GBLX) is ... Understanding ("MOU") with LaurelCo, LLC, an Illinois ... both cultivation and dispensary medical marijuana licenses in the state ... GBLX will acquire a 20% equity interest in LaurelCo, LLC ... growing chambers, as well as all technology related to ...
(Date:7/25/2014)... York , July 25, 2014 ... Transparency Market Research "Global and China Insulin Market (Rapid-Acting, ... Industry Analysis, Size, Share, Growth, Trends and Forecast (Value ... was valued at USD 19.99 billion in 2012 and ... from 2013 to 2019 to reach USD 32.24 billion ...
(Date:7/25/2014)... 2014  Semler Scientific, Inc. (Nasdaq: ... company that develops patented products that assist healthcare ... today reported financial results for the second quarter ... "The second quarter of 2014 continued ... Murphy-Chutorian , M.D., chief executive officer of Semler.  ...
Breaking Medicine Technology:GrowBLOX Sciences, Inc. Partners with LaurelCo, LLC to Obtain Licenses to Cultivate and Dispense Medical Marijuana in Illinois 2GrowBLOX Sciences, Inc. Partners with LaurelCo, LLC to Obtain Licenses to Cultivate and Dispense Medical Marijuana in Illinois 3Global Insulin Market Expected to Reach USD 32.24 Billion Globally in 2019: Transparency Market Research 2Global Insulin Market Expected to Reach USD 32.24 Billion Globally in 2019: Transparency Market Research 3Global Insulin Market Expected to Reach USD 32.24 Billion Globally in 2019: Transparency Market Research 4Semler Reports Second Quarter 2014 Financial Results 2Semler Reports Second Quarter 2014 Financial Results 3
Cached News: