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:
*Name:
*Comment:
*Email:


(Date:5/24/2017)... ... May 24, 2017 , ... In ... choosing the most appropriate instruments for research and understanding the basic principles that ... webinar will focus on innovations in stereo microscopy for brightfield and fluorescence typically ...
(Date:5/24/2017)... Diego, California (PRWEB) , ... May 24, 2017 ... ... care through innovative medical image management and interpretation, has received U.S. Food and ... , Nucleus.io is a web-based, scalable and secure cloud platform for medical ...
(Date:5/24/2017)... ... May 24, 2017 , ... Patients who want to receive cosmetic ... meet with Dr. Joseph Bedich for a consultation, with or without a referral. Dr. ... health and functionality. , Dr. Bedich offers a variety of cosmetic dentistry ...
(Date:5/24/2017)... ... May 24, 2017 , ... Dr. ... of the HP3 (High-Performance Periodontal Practice) continuing education (CE) series. As a compassionate ... in his field by attending numerous CE courses each year. His recent course, ...
(Date:5/24/2017)... ... 2017 , ... Accordant Technology, a trusted IT solutions provider, ... analytics-first approach, layered with machine learning, that provides real-time visibility into the performance, ... to the edge. Through the new partnership, customers get the real-time situational insight ...
Breaking Medicine News(10 mins):
(Date:5/18/2017)... N.J. , May 18, 2017  Two Bayer ... Businesswomen,s Association (HBA) during its recent 28 th ... York City.  The event showcases HBA,s longstanding mission of ... business of healthcare. Cindy Powell-Steffen , ... Bayer,s U.S. Radiology division, and Libby Howe , ...
(Date:5/15/2017)... Enterin Inc., a privately-held CNS pharmaceutical company based ... to treat Parkinson,s disease (PD), has enrolled the first patient ... randomized, controlled, multicenter study involving patients with PD and taking ... over a 9-to-12-month period. The first stage is open label ... Participating sites include Denver , ...
(Date:5/10/2017)... Hologic, Inc. (Nasdaq: HOLX ) announced today ... ended April 1, 2017 .   GAAP diluted earnings ... the prior year period as the sale of the ... non-GAAP diluted EPS of $0.50 increased 6.4%.  Revenue of ... terms.  Excluding the effects of blood screening and the ...
Breaking Medicine Technology:
Cached News: