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:2/9/2016)... ... February 09, 2016 , ... The ... Herberger’s and Younkers department stores, announced it has raised $176,000 to benefit the ... Holden Comprehensive Cancer Center at the University of Iowa, The Lynn Sage Cancer ...
(Date:2/9/2016)... City, Florida (PRWEB) , ... February 09, 2016 ... ... of cold therapy products, announced today the introduction of the newly designed, innovative ... maximum comfort and better cold therapy coverage for the injured arm and shoulder ...
(Date:2/9/2016)... ... 09, 2016 , ... i2i Systems, an early innovator and developer of population ... the latest KLAS report, Population Health Management 2015: How Far Can Your Vendor Take ... health management (PHM). The latest KLAS Report, leveraging over 200 user interviews, shines ...
(Date:2/8/2016)... ... February 08, 2016 , ... ... newly redesigned website, federallabs.org . The site houses a wealth of federal ... federal technologies through the process called technology transfer (T2). As a network of ...
(Date:2/8/2016)... ... February 08, 2016 , ... The Valentine’s Season is famous for gift giving with ... others that they are loved. This year, for more than 5.6 million Americans suffering ... just won't be enough to remind them of the lives they’ve led and the people ...
Breaking Medicine News(10 mins):
(Date:2/9/2016)... February 9, 2016 QGEN ... collaboration with 10x Genomics to develop and promote ... and bioinformatics. --> QGEN ; Frankfurt ... 10x Genomics to develop and promote comprehensive solutions ... --> QIAGEN N.V. (NASDAQ: QGEN ...
(Date:2/9/2016)...   AllCare Plus Pharmacy announced today that ... Approval ® for Home Care Accreditation ... Gold Seal of Approval ® is a symbol ... safe and effective care.  --> ... rigorous on-site survey in January 2016. The survey reflected ...
(Date:2/9/2016)... 2016 Hearing protection devices refer to the ... to the inner ear. Hearing protection devices include earplugs, ... are recommended for users exposed to noise levels of ... HPD that are inserted in the ear canal to ... provide more natural sound perception with the help of ...
Breaking Medicine Technology:
Cached News: