Navigation Links
Roche and FDA Agree on Pathway Towards U.S. Approval of ACTEMRA(R) (tocilizumab)
Date:12/3/2008

NUTLEY, N.J., Dec. 4 /PRNewswire/ -- Roche today announced that the U.S. Food and Drug Administration (FDA) has provided further guidance on the requirements for the Biologics License Application (BLA) for ACTEMRA(R) (tocilizumab), the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody studied for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

As a result of the FDA's evolving Risk Evaluation and Mitigation Strategy (REMS) requirements for medications, the Agency has clarified that a REMS plan is required to help ensure that health care professionals prescribe and administer ACTEMRA correctly, and that patients understand the potential benefits and risks associated with this medication. Additionally, based on the evolving requirements for approval of new biologics, the FDA has asked Roche for non-clinical animal model data, beyond what was included in the ACTEMRA BLA. Roche is performing the requested pre-clinical studies to confirm the published literature showing that ACTEMRA does not affect peri- and post-natal development, and fertility. The FDA has not requested additional clinical studies prior to approval.

The FDA Office of Compliance has also completed its evaluation of the manufacturing facility in Japan, and has indicated that it is acceptable to manufacture ACTEMRA.

In September, Roche received a complete response letter from the FDA for the ACTEMRA BLA. Since then, Roche has been engaged in productive discussions with the FDA and recently met with Agency representatives for clarification on the outstanding components related to the ACTEMRA BLA.

"Roche will continue to work diligently to fulfill the FDA's requirements, and we anticipate submitting the complete response for ACTEMRA to the Agency in the third quarter of 2009," said George Abercrombie, CEO and president of Roche. "Roche remains confident in t
'/>"/>

SOURCE Roche
Copyright©2008 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4 5

Related medicine technology :

1. Roche, InterMune and Pharmasset Announce Initiation of INFORM-1, the First Dual-Combination Clinical Trial with Oral Antivirals in Hepatitis C
2. Memory Pharmaceuticals and Roche Expand R3487/MEM 3454 Development Program
3. National Jewish Health and Roche Diagnostics Corporation Reach Agreement to Pursue Environmental Molecular Diagnostics Opportunities
4. MacroChem Announces Phase 2 Data for EcoNail(R) in the Treatment of Onychomycosis
5. University of Rochester Researcher Named Millennium Pharmaceuticals Career Development Scholar of The Leukemia & Lymphoma Society
6. Roche Moves Investigational Diabetes Drug, Taspoglutide, Into Phase III Clinical Trials
7. New Roche Data to be Presented at ASCO Offers Further Hope for Cancer Patients
8. Roche Exercises its Option to Further Develop and Commercialize Memory Pharmaceuticals Nicotinic Alpha-7 Agonist, MEM 3454
9. Roche Gains Access to Important Oncology Target With Potential for Treating Major Cancers Such as Breast and Lung; First Drug Candidate in Phase I Clinical Testing
10. MacroChem Announces Presentation of Pexiganan Phase 3 Study Results for Topical Treatment of Diabetic Foot Infection
11. Memory Pharmaceuticals & Roche Expand Development Program for MEM 3454 in Schizophrenia

Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/3/2009)..., HOERSHOLM, Denmark and SAN DIEGO, Californ...9 Successfully Inhibits miR-122, a microRNA Import...nificantly Reducing Hepatitis C,Virus in the Blood...e,Hepatitis C Virus , - SPC3649 Demonstra...and,No Serious Adverse Events in the Treated Anima...
(Date:12/3/2009)...MESA, Calif., Dec. 3 TROY Group, ...ing Solutions, announces the addition of the TROY...rescription printing solutions. Based on the HP La...5 SecureRx(TM) Printers provide a fast 42 page per...printing capability and enhanced TROY prescription...
(Date:12/3/2009)...UL, Minn., Dec. 3 Apnex Medical, I...hat it has completed a second round of private equ... be used to complete a clinical study and develop ... technology designed to treat obstructive sleep ap...lude Domain Associates, New Enterprise Associates ...
Breaking Medicine Technology:New Data Shows Breakthrough microRNA-Targeted Therapy Developed Using Santaris Pharma A/S Proprietary LNA Technology Holds Promise as New Treatment for Hepatitis C 2New Data Shows Breakthrough microRNA-Targeted Therapy Developed Using Santaris Pharma A/S Proprietary LNA Technology Holds Promise as New Treatment for Hepatitis C 3New Data Shows Breakthrough microRNA-Targeted Therapy Developed Using Santaris Pharma A/S Proprietary LNA Technology Holds Promise as New Treatment for Hepatitis C 4New Data Shows Breakthrough microRNA-Targeted Therapy Developed Using Santaris Pharma A/S Proprietary LNA Technology Holds Promise as New Treatment for Hepatitis C 5New TROY SecureRx Prescription Printer Marks 50th Hospital Installation Milestone 2Apnex Medical, Inc. Raises Additional $14 Million 2Apnex Medical, Inc. Raises Additional $14 Million 3Surgical Hospital of Oklahoma to Partner with Surgical Care Affiliates 56221 1Surgical Hospital of Oklahoma to Partner with Surgical Care Affiliates 56221 2Amylin Pharmaceuticals to Present at Morgan Stanley Global Healthcare Unplugged Conference 13851 1BioSpecifics Technologies Corp Announces XIAFLEX 28TM 29 CORD I Study Published in New England Journal of Medicine 4941 1BioSpecifics Technologies Corp Announces XIAFLEX 28TM 29 CORD I Study Published in New England Journal of Medicine 4941 2
(Date:12/3/2009)...BO analysis understates key factors contributing t...USNewswire/ -- A new actuarial analysis by Oliver ...ms in the new individual market will be 54 percent...mentation of healthcare reform under the Patient P...ng the impact of medical inflation. This would tr...
(Date:12/3/2009)... Harmful procedures on young women caused by outda...h sues FDA on December 11 for blocking new technol...B) December 2, 2009 -- Now the American College o...at the invasive cancer workup procedure, also know...necessary to some women who have received the proc...
(Date:12/3/2009)...many, PARSIPPANY, N.J. and ANDOVER, Mass., Dec. 3 ...se Image Intelligence® company, and Visage Im... Medicus Ltd. (ASX: PME) announced today that they...p and market advanced oncology solutions for the c...partnership enables Definiens to utilize the Visag...
(Date:12/3/2009)..., N.C., Dec. 3 To honor...th International has created a named award for a ...ident and CEO Pape Gaye presented the inaugural Pa...rize, during a ceremony at the non-profit,s North ...nnual award, IntraHealth seeks to recognize health...
(Date:12/3/2009)... Satori World Medical, a leading global healthcare...el space, announced that international medical qua...s Medical Quality Advisory Board (MQAB). , ..., 2009 –- Satori World Medical, a leading gl...ng medical travel space, announced that internatio...
Breaking Medicine News(10 mins):Health News:New Actuarial Analysis Shows Senate Bill Would Significantly Raise Premiums 2Health News:New Actuarial Analysis Shows Senate Bill Would Significantly Raise Premiums 3Health News:New Actuarial Analysis Shows Senate Bill Would Significantly Raise Premiums 4Health News:Harmful Procedures on Young Women Caused by Outdated HPV test, not by Pap Test 2Health News:Visage Imaging and Definiens Announce Partnership 2Health News:Visage Imaging and Definiens Announce Partnership 3Health News:Inaugural 'Health Worker Leadership Award' Honors Kenyan Midwife, IntraHealth Senior Leader 2Health News:Former Chief Medical Officer of Joint Commission International Joins Satori World Medical's Medical Quality Advisory Board 2Health News:Former Chief Medical Officer of Joint Commission International Joins Satori World Medical's Medical Quality Advisory Board 3Health News:Former Chief Medical Officer of Joint Commission International Joins Satori World Medical's Medical Quality Advisory Board 4
...in C has long been known to give a boost to the bo...and in ensuring good health//. Now, a Christchurch... behind the blessing of Vitamin C, demonstrating t...with a team from the Angiogenesis Research Group a...
...ealand researchers claimed Friday that vitamin C w...cancer by making chemotherapy treatment more effec...sity's Free Radical Research Group, said laborator... a cold. "I've found that vitamin C is absol...
...rch has shown that people who exercise do better o...lly what exercise does within the brain//. Exercis...mpus, known as the dentate gyrus, which underlies ...t-ever observation of neurogenesis, the growth of ...
...al scientists at the University of Leicester and F...n-killing drug//. The composition of the drug and ... on 20th March. Professor David Lambert, who...s many of the side effects of morphine, currently ...
...onvenience to view personal medical records on the...s the core of the novel NHS IT system, slated to s... records, spearheaded by ‘Connecting for Health’ s...his plan will be sent to patients and they will be...
...esearch suggests that a child’s race may be a fact...o toxins associated with environmental tobacco smo...n children with asthma, who are exposed to ETS, ha...co-related disorders, such as asthma, sudden-infan...
Other Medicine News:Health News:Vitamin C Could Help in Curbing Cancer 2Health News:New Reason to Hit the Gym: Fighting Memory Loss 2Health News:Race Affects Tobacco Absorption in Children 2
Premier Thumb Spica
FREEDOM® Memory Thumb Spica
QualCraft™ Gamekeeper Thumb Stabilizer
...dom® CMC ThumbFit™ reduces joint instabi...ofile splint is remarkably comfortable and easy fo... CHT and Robert V. Sypher Jr., MD, FAAOS, develope...plaints of discomfort and impaired hand function f...
Medicine Products: