X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development

    New Delivery Path Brings To Light Efficacy of Immunotherapy

    Nasal Spray Shows Its Effect Against New COVID Variants

    Mid-Point Regulatory Science Strategy Study Published By EMA

    AADC Inadequacy To Be Handled By A Novel Gene Therapy

    New Drug Explored For Epilepsy Gets $3M Funding In Australia

    Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials

    Faster Clinical Trial Nods Planned By The UK To Curb Issues

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    U.S. FDA Approves DARZALEX Split-Dosing Regimen

    EMA Keeping A Close Watch On Critical Medicine Shortages

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Pathways Laid Down By The CMS For Drug Price Negotiations

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development

    New Delivery Path Brings To Light Efficacy of Immunotherapy

    Nasal Spray Shows Its Effect Against New COVID Variants

    Mid-Point Regulatory Science Strategy Study Published By EMA

    AADC Inadequacy To Be Handled By A Novel Gene Therapy

    New Drug Explored For Epilepsy Gets $3M Funding In Australia

    Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials

    Faster Clinical Trial Nods Planned By The UK To Curb Issues

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    U.S. FDA Approves DARZALEX Split-Dosing Regimen

    EMA Keeping A Close Watch On Critical Medicine Shortages

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Pathways Laid Down By The CMS For Drug Price Negotiations

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Europe

EMA accepts Merck’s MAA for cladribine tablets in multiple sclerosis

Yuvraj_pawp by Yuvraj_pawp
18th July 2016
in Europe, News

Merck, a leading science and technology company announced that the EMA to request the company for marketing approval for its investigational Cladribine Tablets for the treatment of relapsing multiple sclerosis (MS) to adopted examination.

 

“Our marketing authorization application for Cladribine Tablets underpins our ongoing commitment to a successful treatment of multiple sclerosis with their severe disabilities for those affected,” said Luciano Rossetti, head of global research and development in the biopharmaceutical business of Merck. “Although there are some therapies for relapsing-remitting MS, there is still a large unmet need, especially in terms of effectiveness, dosing schedule, durability and safety. We are convinced that in case of approval with Cladribine Tablets stands a unique dosing regimen and an important treatment option for patients with relapsing forms of MS available. ”

 

The NDA includes data from three Phase III studies: CLARITY, CLARITY EXTENSION and ORACLE MS and the phase II study ONWARD. In these studies with Cladribine Tablets in patients with relapsing-remitting MS compared to placebo, a significant reduction in relapse rate, the risk of disability progression and the development of new, made in MRI visible MS lesions. 1,2,3,4,5 Together with the interim data from the long-term follow from the prospective registry PREMIERE includes the new application for admission and follow-up data, which include more than 10,000 patient-years of exposure, with some patients were followed for more than eight years. 6

 

literature
. 1 A Placebo-Controlled Trial of Oral Cladribine for Relapsing Multiple Sclerosis. New England Journal of Medicine .Http://www.nejm.org/doi/full/10.1056/NEJMoa0902533 , called on 5 May 2016th
2. Safety and Efficacy of Oral Cladribine in Patients with Relapsing-Remitting Multiple Sclerosis: Results from the 96 Week Phase IIIb Extension Trial to the CLARITY Study (P07.119). called on 5 May 2016th
3. Effect of Oral Cladribine on Time to Conversion to Clinically Definite Multiple Sclerosis in Patients with a First Demyelinating Event (ORACLE MS): A Phase 3 Randomised Trial. Lancet Neurology.Http://www.ncbi.nlm.nih.gov/pubmed/24502830 , called on 5 May 2016th
4. A Phase 2 Study of Cladribine add-on to interferon-beta (IFN-beta) Therapy in Multiple Sclerosis (MS) Subjects With Active Disease (ONWARD). Clinical called on 5 May 2016th
5. Efficacy of Cladribine Tablets as an add-on to IFN-beta Therapy in Patients with Active Relapsing MS: Final Results from the Phase II ONWARD Study. American Academy of Neurology 2016 meeting abstracts.Http://www.abstractsonline.com/pp8/#!/4046/presentation/9728 , called on 10 May 2016.
6. Current and Emerging Therapies for the Treatment of Multiple Sclerosis. Focus on Cladribine Journal of Central Nervous System Disease . Http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3619698/called on June 14, 2016

 

Cladribine Tablets
In the preparation Cladribine Tablets is an oral low-molecular prodrug that selectively targets and periodically on lymphocytes, which are to be heavily involved in the pathological process of MS. Cladribine Tablets are currently in clinical trials and are not yet in the US, Canada and Europe approved for the treatment. Multiple Sclerosis Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system and the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.3 million people have MS worldwide. The symptoms can vary, the mainly blurred vision, numbness or tingling in the limbs and loss of strength and coordination problems. Are the most common, the relapsing forms of MS.

Tags: Europe
Previous Post

Biogen SB5 accepted for review by European Medicines Agency

Next Post

AstraZeneca receives approval in the EU for Qtern for treatment of Type 2 diabetes

Related Posts

Drug Development

New Delivery Path Brings To Light Efficacy of Immunotherapy

1st April 2023
Quotient Sciences completes integration of drug substance into Translational Pharmaceutics Platform
Facilities & Operation

£277m Funding Set To Benefit UK Life Sciences Manufacturing

31st March 2023
Drug Development

Nasal Spray Shows Its Effect Against New COVID Variants

27th March 2023
FDA Approvals

Mid-Point Regulatory Science Strategy Study Published By EMA

27th March 2023
Drug Development

AADC Inadequacy To Be Handled By A Novel Gene Therapy

24th March 2023
Drug Development

New Drug Explored For Epilepsy Gets $3M Funding In Australia

23rd March 2023
Next Post

AstraZeneca receives approval in the EU for Qtern for treatment of Type 2 diabetes

Latest News

Drug Development

New Delivery Path Brings To Light Efficacy of Immunotherapy

1st April 2023
Cathay Cargo signs global airline partnership with Tower Cold Chain
Packaging & Logistic

Cathay Cargo signs global airline partnership with Tower Cold Chain

31st March 2023
Quotient Sciences completes integration of drug substance into Translational Pharmaceutics Platform
Facilities & Operation

£277m Funding Set To Benefit UK Life Sciences Manufacturing

31st March 2023
Drug Development

Nasal Spray Shows Its Effect Against New COVID Variants

27th March 2023
FDA Approvals

Mid-Point Regulatory Science Strategy Study Published By EMA

27th March 2023
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack

System

  • Search
  • Sitemap
  • RSS Feed

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In