Amgen Kineret demonstrates efficacy
This article was originally published in Pharmaceutical Approvals Monthly
FDA Arthritis Advisory Committee decides Aug. 16 in a 6 to 2 vote that Amgen's rheumatoid arthritis agent Kineret (anakinra) demonstrated efficacy, but says efficacy is "modest" in comparison to methotrexate. An interim analysis of 506 patients found a higher response rate for combo therapy with anakinra plus methotrexate vs. methotrexate alone. Based on results from an open-label study showing a higher rate of infection in patients receiving anakinra plus Immunex' Enbrel (etanercept), the committee recommended that anakinra labeling should have a strong warning against use with TNF-inhibitors, pending results of a double-blind safety trial with etanercept
You may also be interested in...
Cosmetics Europe Talks Microplastic: ECHA Frustrations, ‘Value Judgments’ And International Trade Uncertainty
The European Chemicals Agency's microplastic restriction proposal received committee backing in 2020 without changes sought by the cosmetics industry, which faces €15bn in projected costs and scarce alternatives at present. It may come down to EU Member States to decide whether the ECHA restriction proposal is proportionate in balancing environmental goals and socio-economic impacts.
Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.
To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.