Regulatory Index News: 27/04/2018

Welcome to your Regulatory Index News update today. Read here to keep up to date with a recent FDA rejection, FDA approval and mixed review by advisory panel.

Pfizer’s Herceptin biosimilar rejected by US regulators

The FDA have declined Pfizer’s Herceptin biosimilar for approval and instead issued a Complete Response Letter (CRL) for further technical information. Pfizer have released a statement that the request is not safety or clinical data related however they did not address what the request was or how long it might take to resolve. Whilst the request does not appear damning for the biosimilar, it has setback the company's access to the $7billion market which Herceptin dominates. Pfizer have had a mixed success in the biosimilar drug development field, where they have previously won two US approvals for separate versions of Janssen’s Remicade, however they have failed to secure an approval for Amgen’s Epogen and now Roche’s Herceptin. Please click here to read further from a BioPharmaDIVE article.

FDA expands scope for GSK/Innoviva’s Trelegy Ellipta

The US regulators have approved the expanded scope of Trelegy Ellipta to treat a wider population of chronic obstructive pulmonary disease (COPD). This new approval allows for the use of a single inhaler, which combines fluticasone furoate, umeclidinium and vilanterol (FF/UMEC/VI), as a maintenance therapy for airflow obstruction and exacerbations in COPD patients who are higher risk. The approval was based upon clinical data (IMPACT) which showed Trelegy Ellipta was superior compared to dual therapies (FF/VI and UMEX/VI) for several endpoints including exacerbation rates, lung function and health related quality of life. If you would like to read more on this, please click here for an article from PharmaTimes.

Lilly’s baricitinib hopes challenged

A lower dose of Lilly’s baricitinib has recently been recommended for FDA approval by an advisory committee, however the drug is likely to still face a challenge in reaching the market due to concerns about its safety data. The committee voted 10-5 in favour for approving the 2mg dose for patients with moderate-to-severe rheumatoid arthritis (RA) who do not adequately respond to, or are intolerant to, methotrexate. However, the committee voted 10-5 against the approval of the 4mg dose for the same indication due primarily to blood clots where, across four pivotal late-stage studies, thrombotic events have been recorded in 7 out of 100 patient years of exposure. The placebo and 2mg dose groups on the other hand showed just 1 or 2 events respectively but were only investigated in a smaller pool. Please click here to read for more from a BioPharmaDIVE article.

M L

Author

Max Lymbery

Date Published

27th April 2018

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