The REvalMed coordinating group has finalized reports on Blincyto (blinatumomab) in adults in monotherapy for the treatment of CD19-positive and refractory or relapsed B-precursor acute lymphoblastic leukemia (ALL), Vazkepa (ethyl icosapent) in reducing the risk of cardiovascular events in statin-treated adult patients at high cardiovascular risk, Bylvay (odevixibat) in progressive familial intrahepatic cholestasis (PFIC), Tepmetko (tepotinib) in the treatment of adult patients with advanced non-small cell lung cancer (NSCLC), Inbrija (levodopa) in the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease (PD) and Imfinzi (durvalumab) in the first-line treatment of adults with extended-stage small-cell lung cancer (SCLC-EE).
At its latest meeting, held July 28th, REvalMed group has agreed to start work on the Therapeutic Positioning Reports (TPRs) for vutrisiran, voclosporin, tirzepatide, fosdenopterin, relatlimab / nivolumab, teclistamab, tezepelumab and faricimab, which have a positive opinion from the EMA’s Committee for Medicinal Product Assessment (CHMP).
Amvuttra (vutrisiran), from Alnylam Netherlands, is indicated for the treatment of hereditary transthyretin amyloidosis (ATTRh) in adult patients with stage 1 or 2 polyneuropathy. Lupkynis (voclosporin), from Otsuka Pharmaceutical Netherlands, is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active lupus nephritis class III, IV, or V (including mixed classes III/V and IV/V). Mounjaro (tirzepatide), developed by Eli Lilly Nederland, indicated for the treatment of adults with inadequately controlled type 2 diabetes mellitus, as an adjunct to diet and exercise, both in monotherapy, when metformin is not considered appropriate due to intolerance or contraindications and as an addition to other drugs for the treatment of diabetes.
Nulibry (fosdenopterin), from Comharsa Life Sciences, is indicated for the treatment of patients with type A molybdenum cofactor deficiency. Opdualag (relatlimab / nivolumab) was developed by Bristol-Myers Squibb Pharma EEIG, and is indicated for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years and older with PD-L1 expression < 1% in tumor cells.
Tecvayli (teclistamab), from Janssen-Cilag International, is a monotherapy treatment for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior treatments, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and who have had disease progression to the last treatment.
The licensee of Tezspire (tezepelumab) is AstraZeneca. The drug is indicated as additional maintenance therapy in adults and adolescents 12 years and older with severe asthma who are not adequately controlled despite the administration of high-dose inhaled corticosteroids in combination with another drug for maintenance therapy.
Roche’s Vabysmo (faricimab) is indicated for the treatment of adult patients with neovascular (exudative) age-related macular degeneration and visual impairment due to diabetic macular edema.
The group will perform the IPTs for the new indications or indication extensions for Imcivree (setmelanotide), Retsevmo (selpercatinib), Tecartus (brexucabtagene autoleucel) and Ultomiris (ravulizumab).
In accordance with the REvalMed Plan, all the agreed IPTs will be carried out, applying the criteria approved by the Standing Committee on Pharmacy for their prioritization.
Likewise, it was agreed to initiate the following IPT as a pilot project in accordance with the new procedure of the REvalMed Plan: Tezspire (tezepelumab).
Read more on the subject and find the latest business news of the day with the Born2Invest mobile app.
In general, IPTs of combinations of already authorized active ingredients will not be carried out, except in those cases in which the AG considers it necessary
The AG reminds that, in order to maximize the available resources, and until a definitive procedure is established, authorization holders of drugs with a positive opinion from the CHMP are requested to contact the group’s secretariat, indicating whether or not they intend to market in Spain the new drugs that have obtained a positive opinion by centralized procedure prospectively since the publication of this document, and also providing a contact point for the holder for aspects related to the AG. If no marketing confirmation is received, the preparation of the report will not begin.
Similarly, in the event of withdrawals of the marketing authorization, changes in the ownership of the drug, or in the intention to market it, the information should be communicated to the e-mail addresses indicated above.
The next AG meeting will take place on September 22, 2022.
DISCLAIMER: This article was written by a third party contributor and does not reflect the opinion of Born2Invest, its management, staff or its associates. Please review our disclaimer for more information.
This article may include forward-looking statements. These forward-looking statements generally are identified by the words “believe,” “project,” “estimate,” “become,” “plan,” “will,” and similar expressions. These forward-looking statements involve known and unknown risks as well as uncertainties, including those discussed in the following cautionary statements and elsewhere in this article and on this site. Although the Company may believe that its expectations are based on reasonable assumptions, the actual results that the Company may achieve may differ materially from any forward-looking statements, which reflect the opinions of the management of the Company only as of the date hereof. Additionally, please make sure to read these important disclosures.
First published in diariofarma, a third-party contributor translated and adapted the articles from the originals. In case of discrepancy, the original will prevail.
Although we made reasonable efforts to provide accurate translations, some parts may be incorrect. Born2Invest assumes no responsibility for errors, omissions or ambiguities in the translations provided on this website. Any person or entity relying on translated content does so at their own risk. Born2Invest is not responsible for losses caused by such reliance on the accuracy or reliability of translated information. If you wish to report an error or inaccuracy in the translation, we encourage you to contact us.
How Much Do We Know About Sustainability: The ESG Culture LAB Report
From the results that emerge from the Eikon Italia survey, although citizens have only a partial vision of sustainability, more...
How a Newly Launched Bitcoin ETF Is Seen by Investors
The Bitcoin ETF Token (BTCETF) is a project issued on the Ethereum blockchain. Its native token is BTCETF and is...
Walliance Buys Lymo, the First French Real Estate Crowdfunding Platform
Walliance, with the inclusion of Lymo Finance, has solidified its position with over €160 million transacted, boasting around 98,000 registered...
Mediquo Is Committed to the International Market and Aims to Double Sales in 2024
Mediquo makes it possible for any healthcare professional to care for their patients via chat. Last April, the Catalan company...
Why the Agrifood Industry in Morocco is a Strategic Challenge
The organization of an international agrifood trade show in Morocco would be a key lever for stimulating local exports and...
Crypto1 week ago
Cryptocurrencies Kick Off the Milei Era with 30% Increase
Business3 days ago
Vivid Seats Acquires Vegas.com in $240M Transaction — Is Restaurant.com [RDE, Inc. | OTCQB: RSTN] Next in Line?
Business1 week ago
CardCash.com [RDE, Inc. | OTCQB: RSTN] Is Turning Unwanted Gift Cards Into Investor Profits — Here’s How
Fintech2 days ago
How the Fintech Sector in Mexico Developed