HOME >> MEDICINE >> NEWS
Immunex Files Supplemental NDA for NOVANTRONE

Company seeks priority review of NOVATRONE in secondary progressive Multiple Sclerosis

SEATTLE - Immunex Corporation (NASDAQ:IMNX) announced today that it has filed a supplemental NDA with the U.S. Food and Drug Administration (FDA) for expanded labeling for NOVANTRONE® (mitoxantrone for injection concentrate) for the treatment of patients with secondary progressive Multiple Sclerosis (MS).

"There are 120,000 patients with secondary progressive MS for whom there are still no approved treatment options," said Peggy V. Phillips, senior vice president, pharmaceutical development for Immunex. "Patients with this form of the disease experience a steady worsening of their neurological function which can result in loss of control over movement of limbs and impaired vision and speech. We are pleased to be filing this and we have asked the FDA for priority review."

The results of the pivotal NOVANTRONE Phase III data submitted to the FDA today showed that NOVANTRONE had a statistically significant impact on relapse rate and disability progression in patients with secondary progressive MS. These clinical data were corroborated by positive magnetic resonance imaging (MRI) data.

This multicenter, placebo-controlled, randomized, observer-blind study of 194 patients compared two doses of NOVANTRONE -- 12 mg/m2 and 5 mg/m2 - with placebo. Each treatment was administered by short, IV infusion once every three months for two years. These results were reported at the September 1998 Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

Additional third-year follow-up data were presented in April of this year at the Annual Meeting of the American Academy of Neurology (AAN). These results showed that one year after treatment was stopped, patients who had been treated with NOVANTRONE experienced a sustained reduction in their number of attacks, and delay in their disab
'"/>

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


Page: 1 2 3

Related medicine news :

1. Immunex Advances CD40 Ligand To Phase II Clinical Trial In People With Metastatic Kidney Cancer
2. Immunexs TRAIL Molecule Shows Potential As Anti-Tumor Agent
3. Mad hatters, seafood jubilees, & Pfiesteria Files
4. NOVANTRONE application for multiple sclerosis granted priority review by FDA

Post Your Comments:
*Name:
*Comment:
*Email:


(Date:8/11/2018)... ... 10, 2018 , ... TopConsumerReviews.com recently awarded a five-star rating ... This painful, persistent condition originates in the liver and is characterized by pain ... Other contributing factors may be medication side effects, overweight, and unhealthy diet. The ...
(Date:8/9/2018)... ... August 09, 2018 , ... Thousands ... have ruptured, according to cross-referenced data from The American Society of Plastic Surgeons ... rupture rates monitored by the FDA. As an MRI is recommended by FDA ...
(Date:8/9/2018)... , ... August 09, 2018 , ... ... been engaged as an Operating Partner and will have an exclusive relationship with ... role in the firm’s strategic planning, human capital sourcing, and deal origination, evaluation ...
(Date:8/7/2018)... ... August 07, 2018 , ... Today Springfield Creamery added six ... rich, cream-on-top-style yogurts are made with milk from grass-fed cows who enjoy a ... fatty acids. Nancy’s sources the milk from organic family-owned farms, all within 60 ...
(Date:8/3/2018)... ... 2018 , ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh, ... the Bible meant only to be understood in this current generation. Yisrayl says he ... decode passages that he says scholars have struggled with for generations. Yisrayl says the ...
Breaking Medicine News(10 mins):
(Date:8/14/2018)... , ... August 14, 2018 , ... ... Academy, their first-ever summer harvest employment and hands-on educational program developed for students ... in a high school, junior college or university, spent a minimum of 6 ...
(Date:8/11/2018)... ... August 10, 2018 , ... Last month, Dr. Tim Herman, Lead Dentist at ... care in underserved communities surrounding its capital of Asunción. Along with a team of ... his time to help deliver care to over 550 individuals in need. , Outreaches ...
(Date:8/9/2018)... ... ... Autism is a developmental disorder affecting more than 3.5 million Americans’ ability ... 68 people have the disorder), chances are you know someone on the autism spectrum! ... autism methods of communication and tactics to interact with others. These options help set ...
Breaking Medicine Technology:
Cached News: