Daclizumab Passes Phase III Hurdles

Daclizumab Passes Phase III Hurdles

DaclizumabExciting news has been shared by Abbvie and Biogen regarding Daclizumab and it’s now brighter future. The once a month treatment for MS has now cleared all major Phase III hurdles, making a marketing pitch to FDA regulators foreseeable in the near future. As an injectable medication designed to combat the debilitating symptoms of Multiple Sclerosis, or MS, Phase III results demonstrated a 45 percent drop in the yearly relapse rate for the patients who received Daclizumab. This percentage is statistically significant for a CD25 blocker. Additionally, Daclizumab sizably reduced the number of new enlarging T2 hyperintense lesions. This occurred at approximately 96 weeks into the study, showing a 54 percent reduction as compared to competitor Avonex. While there were several adverse effects, such as serious infections and cutaneous reactions the vast majority of the 1,800 participant study did very well.

CD40L ExpressionDaclizumab has proven to be an efficacious treatment for Multiple Sclerosis, as it inhibits the survival of activated T cells as well as CD40L expression. The administration of Daclizumab also decreases the amount of circulating lymphoid cells, which are usually elevated in patients who have not yet received treatment for MS. The SELECT study of Daclizumab, which was published in 2013, demonstrated the power of this drug as a humanized monoclonal antibody of IgG1 subtype. The design of Daclizumab to act as a therapy which selectively inhibits the T-cell activation makes this formidable treatment unstoppable. By inhibiting organ inflammation, activating immunoregulatory CD56 NK cells and modulating the development of innate lymphoid cells Daclizumab is proving to be an advantageous and effective treatment broad spectrum. Continued research and development is underway to ultimately gain the FDA approval for this phenomenal drug.

LGM Pharma is a provider of API Daclizumab, CAS 152923-56-3 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

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LGM Pharma Acquires CDMO

On July 27, 2020, LGM Pharma announced its acquisition of the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. As a result, you will notice our new logo and visuals throughout the website. We’re working on updates to reflect the exciting, expanded CDMO capabilities and services we now can offer you.

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