A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from AstraZeneca, Teva, Sanofi, and Bayer.

Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday, December 13, 2017 to Tuesday, January 9, 2017.

FDA Accepts AstraZeneca’s sNDA for Lung Cancer Drug Tagrisso
The US Food and Drug Administration (FDA) has accepted AstraZeneca’s supplemental new drug application (sNDA) for Tagrisso (osimertinib), an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor with clinical activity against central nervous system (CNS) metastases, for treating patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution mutations).

The FDA further granted Tagrisso priority review and had previously granted breakthrough therapy designation in treating patients with metastatic EGFR mutation-positive NSCLC.

Tagrisso is currently approved in more than 50 countries, including the US, EU, Japan, and China, as a second-line treatment for patients with advanced NSCLC who progress following treatment with an EGFR TKI due to the EGFR T790M resistance mutation.

Source: AstraZeneca

FDA Grants Priority Review for Teva’s Migraine Drug
The US Food and Drug Administration (FDA) has accepted Teva Pharmaceutical Industries’ biologics license application (BLA) for fremanezumab, an anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody for the preventive treatment of migraines.

Additionally, the FDA has granted fast track designation for fremanezumab for preventing cluster headaches. Teva also acquired a priority review voucher to expedite the review of fremanezumab. Regulatory action is anticipated by mid-2018, according to the company.

Source: Teva Pharmaceutical Industries

Sanofi, Alnylam Submit MAA to EMA for RNAi Drug
Sanofi Genzyme, the specialty care global business unit of Sanofi, and Alnylam Pharmaceuticals, a Cambridge, Massachusetts-based biopharmaceutical company focused on RNAi therapeutics, have submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for patisiran, an investigational RNAi therapeutic targeting transthyretin (TTR) for treating adults with hereditary transthyretin-mediated amyloidosis, a progressive condition characterized by the buildup of abnormal deposits of a protein called amyloid (amyloidosis) in the body’s organs and tissues.

Patisiran was previously granted accelerated assessment by the EMA, which potentially reduces the EMA’s evaluation time from 210 to 150 days.

Alnylam completed the submission of a new drug application to the US Food and Drug Administration (FDA) in December 2017. Sanofi Genzyme is currently preparing regulatory filings for patisiran in Japan, Brazil, and other countries, with submissions expected to begin in the first half of 2018. Pending regulatory approvals, Alnylam will commercialize patisiran in the US, Canada, and Western Europe, with Sanofi Genzyme commercializing the product in the rest of the world, including certain Central and Eastern European countries of the European Union.

Source: Sanofi

Bayer Initiates Rolling Submission of NDA for Fusion Cancers
Bayer and its partner Loxo Oncology, a Stamford, Connecticut-based biopharmaceutical company, have initiated the submission of a rolling new drug application (NDA) to the US Food and Drug Administration (FDA) for larotrectinib, a potential anti-cancer therapy.

The NDA is being submitted for treating unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments. Bayer and Loxo are jointly developing larotrectinib, an investigational compound being studied globally for treating patients with cancers harboring tropomyosin receptor kinase (TRK) gene fusions, which are genetic alterations present across a wide range of tumors resulting in uncontrolled TRK signaling and tumor growth. Loxo expects to complete the NDA submission in early 2018.

Source: Bayer

FDA Advisory Committee Recommends Takeda’s Crohn’s Disease Drug
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies, have recommended a marketing authorization for an investigational compound, Cx601 (darvadstrocel), from Takeda Pharmaceutical Company and TiGenix, a ‎Leuven, Belgium-headquartered biopharmaceutical company.

Cx601 is being evaluated for treating complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy.

Source: TiGenix