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
Immunex Corporation

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:6/24/2016)... ... , ... Comfort Keepers® of San Diego, CA is excited to announce they ... to drive cancer patients to and from their cancer treatments. Comfort Keepers provides ... life and ongoing independence. Getting to and from medical treatments is one of ...
(Date:6/24/2016)... ... ... People across the U.S. are sharpening their pencils and honing their writing skills ... patients and their families pay tribute to a genetic counselor by nominating him or ... Counselors (NSGC) Annual Education Conference (AEC) this September. , In April, Genome magazine ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Haute Beauty ... Barry M. Weintraub as a prominent plastic surgeon and the network’s newest partner. ... and the most handsome men, look naturally attractive. Plastic surgery should be invisible.” ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... the Frederick area economy by obtaining investment capital for emerging technology companies. ... years that have already resulted in more than a million dollars of capital ...
(Date:6/24/2016)... ... June 24, 2016 , ... Venture Construction Group (VCG) ... held on June 20th at the Woodmont Country Club at 1201 Rockville Pike, Rockville, ... dedicated to helping service members that have been wounded in battle and their families. ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... 2016 , , , WHEN: ... 2016 , , , , LOCATION: , , , Online, ... , , EXPERT PANELISTS:  , , , Frost & Sullivan,s Global ... Bird; Senior Industry Analyst, Divyaa Ravishankar and Unmesh Lal, Program Manager ... pharmaceutical industry is witnessing an exceptional era. Several new demand spaces, ...
(Date:6/23/2016)... -- Astellas today announced the establishment of Astellas Farma Colombia (AFC), a new affiliate with operations headquartered in ... . ... ... ... Astellas is ...
(Date:6/23/2016)... June 23, 2016  Guerbet announced today that it ... Supplier Horizon Award . One of 12 ... recognized for its support of Premier members through exceptional ... excellence, and commitment to lower costs. ... recognition of our outstanding customer service from Premier," says ...
Breaking Medicine Technology:
Cached News: