AstraZeneca, Eisai, GlaxoSmithKline, and Janssen Lead Pipeline News

A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from AstraZeneca, Eisai, GlaxoSmithKline, and Janssen.

Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday November 16, 2016 to Tuesday November 29, 2016.

FDA Lifts Hold on AstraZeneca Cancer Drug Trial
The US Food and Drug Administration (FDA) has lifted the partial clinical hold on clinical trials for AstraZeneca’s anti-cancer antibody drug candidate, durvalumab. The FDA lifted the partial hold following a review of analysis provided by AstraZeneca of bleeding events that were observed as part of the routine safety monitoring of two Phase III trials.

The clinical-trial hold affected the enrolment of new patients with head and neck squamous cell carcinoma (HNSCC) in clinical trials of durvalumab as monotherapy and in combination with tremelimumab or other potential medicines. AstraZeneca has re-opened new patient enrollment at some clinical study sites and is expected to resume recruitment shortly, without amendments to protocol.

AstraZeneca will progressively resume enrolment for all HNSCC trials across the participating sites in the US and globally, subject to national health authority and ethics committee approval where required.

Source: AstraZeneca

FDA Fast Tracks Eisai’s Alzheimer’s Disease Drug
Eisai has been granted fast track designation by the US Food and Drug Administration for the development of E2609, a beta secretase-cleaving enzyme (BACE) inhibitor being investigated for treating early Alzheimer’s disease. The drug was discovered by Eisai and is being jointly developed by Eisai and Biogen.

E2609 is an investigational oral candidate that is believed to inhibit BACE, an enzyme that plays a role in the production of amyloid beta (Aβ) which can form toxic peptide aggregates and amyloid plaques in the brain. By inhibiting BACE, the drug can potentially slow disease progression, Eisai said.

Source: Eisai

GSK Files Respiratory Triple Combo Drug with FDA
GlaxoSmithKline (GSK), with its partner Innoviva, a Brisbane, California-based pharmaceutical company, has filed a regulatory submission with the US Food and Drug Administration for a closed triple combination therapy, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg), for treating chronic obstructive pulmonary disease. This follows the announcement earlier this year of plans to bring forward the timing of the US filing. GSK had originally planned to file for regulatory submission in the first half of 2018

The closed triple combination therapy is a once-daily product that comprises three medicines: fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist. The therapy is delivered in GSK’s Ellipta dry-powder inhaler.

A regulatory filing in the European Union is planned in the coming weeks and is expected to be followed by submissions in other countries beginning in 2017. The closed triple combination of FF/UMEC/VI is not approved for use anywhere in the world, according to the company.

Source: GlaxoSmithKline

GSK Seeks EMA Approval for Shingles Vaccine
GlaxoSmithKline (GSK) has submitted a marketing authorization application to the European Medicines Agency seeking approval for its candidate shingles vaccine, Shingrix, a non-live, recombinant vaccine. GSK is seeking approval of the vaccine for preventing herpes zoster (shingles) in people aged 50 years or older.

The submission to the EMA follows regulatory submissions to the US Food and Drug Administration in October 2016 and to Canadian regulatory authorities earlier in November 2016, with a submission to Japanese regulatory authorities planned for 2017.

The candidate vaccine combines glycoprotein E, a protein found on the varicella zoster virus that causes shingles, with an adjuvant system, AS01B, which is intended to enhance the immunological response to the antigen3. GSK intends to register the product as Shingrix, subject to approval by relevant regulatory review bodies.

Source: GlaxoSmithKline

Janssen Seeks Approval for Psoriasis Biologic
Janssen Biotech, a Johnson & Johnson company, has submitted a biologics license application to the US Food and Drug Administration seeking approval for guselkumab, a human monoclonal antibody for treating adults living with moderate-to-severe plaque psoriasis. Guselkumab targets interleukin-23, a protein which has been shown to play a role in the development of immune-mediated inflammatory diseases.

In related news, Janssen-Cilag International, also Johnson & Johnson company, has submitted a marketing authorization application to the European Medicines Agency (EMA) seeking approval of guselkumab for the same indication.

Source: Johnson & Johnson for FDA submission and for EMA submission

FDA Grants Merck & Co.’s Cancer Drug Priority Review
The US Food and Drug Administration (FDA) has accepted for review Merck & Co.’s supplemental biologics license application for Keytruda (pembrolizumab), the company’s anti-programmed death-1 therapy, for treating previously treated patients with advanced microsatellite instability-high cancer (MSI-H). The application is seeking approval for Keytruda at a fixed dose of 200 mg every three weeks.

The FDA granted priority review with a target action date of March 8, 2017. The FDA recently granted breakthrough therapy designation to Keytruda for unresectable or metastatic MSI-H non-colorectal cancer, and previously granted it for the treatment of patients with unresectable or metastatic MSI-H colorectal cancer.

In the US, Keytruda is indicated for melanoma, lung cancer, and head and neck cancer. The drug is positioned as a potential blockbuster for Merck with projected sales of $3.5 billion in 2019, according to a Thomson Reuters analysis

Source: Merck & Co.

FDA Accepts Merck KGaA’s Cancer Biologic for Priority Review
The US Food and Drug Administration (FDA) has accepted Merck KGaA’s biologics license application (BLA) for avelumab, an investigational fully human anti-programmed death-ligand 1 immunoglobulin G1 monoclonal antibody, for treating an aggressive type of skin cancer known as metastatic Merkel cell carcinoma (MCC). The FDA has granted priority review status to the BLA, which was submitted by EMD Serono, the biopharmaceutical business of Merck KGaA.

The FDA’s priority review status reduces the review time from 10 months to a goal of six months from the day of filing and is given to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists. The FDA previously granted avelumab orphan drug designation for MCC as well as fast track and breakthrough therapy designations for treating patients with MCC whose disease has progressed after at least one previous chemotherapy regimen.

In addition, the European Medicines Agency has validated for review Merck KGaA’s marketing authorization application for avelumab, for the proposed MCC indication.

Source: Merck KGaA

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