Regulatory Index News: 01/05/2018

Welcome to your Regulatory Index News update today. Allergan report continued success for ubrogepant, an anti-drug antibody case has been flagged for Hemlibra and Tagrisso is backed for EU expansion.

Allergan report second phase 3 success for ubrogepant in migraines

Allergan’s oral CGRP drug has succeeded in reaching both of its co-primary endpoints in a second phase 3 migraine trial, further confirming the company’s plans to file for marketing authorisation in 2019. The study has enrolled 1,686 patients to investigate a 25mg and 50mg dose of ubrogepant against a placebo to treat moderate-to-severe single migraine attacks. The 50mg dose has met both of its co-primary endpoints where after two hours, about 20% of patients in the treatment arm were pain-free compared to 14% in the placebo group. The 50mg dose also reduced the frequency of the most bothersome migraine-associated symptoms (light and noise sensitivity) where after two hours, almost 39% of patients receiving 50mg reported loss of the symptoms from almost 27% with the placebo. Please click here if you would like to read further on this story from FierceBiotech.

Roche flags first case of anti-drug antibodies to Hemlibra in phase 3 study

Roche have warned of the first hemophilia patient to develop anti-drug antibodies which rendered Hemlibra treatment ineffective. The patient was taking part in a phase 3 trial (HAVEN 2) when they developed the antibody which reduced its efficacy, and now the patient has discontinued with the treatment to resume his previous medicine. With over 600 people worldwide having been treated with the medicine, this is the first report of a detectable anti-drug antibody for Hemlibra which is distinct from the development of factor VIII inhibitors. With analyst predictions of up to $5 billion peak sales, Roche have great expectations for Hemlibra as a blockbuster but only time will tell as their global roll out continues. If you would like to read more, please click here for an Endpoints article.

EU Regulatory advisors back AstraZeneca’s Tagrisso for first-line lung cancer therapy

The Committee for Medicinal Products for Human Use (CHMP) have recommended the expansion of Tagrisso’s label to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations in the first-line setting. The recommendation was based on clinical data (FLAURA) that was also the foundation for US approval. This data showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) over the standard of care (EGFR-TKIs) where PFS was 18.9 months for patients taking Tagrisso compared to 10.2 months in those receiving standard of care. Please click here for any additional information from a PharmaTimes article.



Max Lymbery

Date Published

01st May 2018

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