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Treatment options for Crohn’s disease expand after Rinvoq approval

Pharmaceutical Technology

The FDA nod means Rinvoq is now approved for seven indications in gastroenterology, rheumatology and dermatology. In a January presentation, the company shared that approvals in additional indications would allow Rinvoq and Skyrizi, a monoclonal antibody, to gain peak share in the different markets, including inflammatory bowel disease.

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Leo puts target on Dupixent in US as FDA clears tralokinumab

pharmaphorum

Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma’s rival antibody tralokinumab. It continues to grow strongly with Sanofi reporting a 53% rise in sales to more than $4.1 billion in the same year. billion in 2020. billion in 2020.

Sales 103
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Risk adjusted net present value: What is the current valuation of Novartis’s Gevokizumab?

Pharmaceutical Technology

Gevokizumab is a monoclonal antibody commercialized by Novartis, with a leading Phase I program in Metastatic Renal Cell Carcinoma. According to Globaldata, it is involved in 34 clinical trials, of which 20 were completed, 1 is ongoing, and 13 were terminated. The company offers generic medicines and biosimilars through Sandoz.

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FDA grants speedy review to Dupixent rare skin disease

pharmaphorum

The review is based on a pair of phase 3 trials of Dupixent in PN patients whose symptoms were inadequately controlled with current drugs. The drug has become a powerhouse for revenues at Sanofi and Regeneron, with the company pitching at peak sales of €10 billion ($10.75

Sales 109
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Dupixent scores a first in rare skin disease prurigo nodularis

pharmaphorum

The two companies are still waiting for the results of a second phase 3 trial, due in the first half of next year, but if that is positive expect to file for approval of Dupixent (dupilumab) in the new indication before the end of 2022. PN is among a clutch of additional indications that could account for upwards of $2 billion of that total.

Trials 105
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LEO Pharma’s Adtralza approved by MHRA, EC for adolescent atopic dermatitis

pharmaphorum

The EC and MHRA approvals are supported by data from the phase 3 ECZTRA 6 trial, and are valid for all European Union Member States, including Ireland and Northern Ireland, as well as Iceland, Norway, and Liechtenstein. The ECZTRA (ECZema TRAlokinumab trial No.6)

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FDA clears Dupixent as first drug for rare skin disorder

pharmaphorum

The disorder – driven by type 2 inflammation characterised by an antibody-based immune response – causes hard lumps or nodules to form on the skin that are so itchy they can lead patients to scratch themselves to the point of bleeding or pain. The suffering he notes from the #itch is 100… [link]. — Brian S.

Drugs 69