Amgen, AstraZeneca, Merck & Co., Novartis, and Sanofi Lead Pipeline News

A roundup of the latest drug pipeline news, including from the pharmaceutical majors, featuring news from Amgen, AstraZeneca, Merck & Co., Novartis, and Sanofi. 

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday May 17, 2017 to Tuesday May 23, 2017.

EMA Advisory Committee Recommends Sanofi’s Biosimilar of Insulin Lispro
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of Sanofi’s insulin lispro Sanofi (insulin lispro 100 units/mL) for treating adults and children who have diabetes and need insulin to keep their blood sugar level controlled, including those patients whose diabetes has just been diagnosed. This positive opinion is the company’s first major regulatory milestone for a biosimilar diabetes treatment.

Insulin lispro Sanofi is a biosimilar of insulin lispro, a rapid-acting insulin analog, produced using recombinant DNA technology and has the identical amino acid sequence as its reference product, Eli Lilly and Company’s Humalog. Humalog was Lilly’s top-selling drug in 2016 with global sales of $2.8 billion. 

The European Commission is expected to make a final decision on marketing authorization for Insulin lispro Sanofi in the coming months.

Source: Sanofi

Amgen Submits a BLA for Migraine Drug
Amgen has submitted a biologics license application to the US Food and Drug Administration for erenumab, a drug for preventing migraines. The drug is part of a pact, formed in 2015, between Amgen and Novartis for developing drugs to treat migraines and Alzheimer’s disease.

Erenumab is a human monoclonal antibody specifically designed to prevent migraine by blocking the calcitonin gene-related peptide (CGRP) receptor, which has been thought to play a causal role in migraine pathophysiology. Erenumab has been studied in several large global, randomized, double-blind, placebo-controlled trials to assess its safety and efficacy in migraine prevention.

In August 2015, Amgen entered into a global collaboration with Novartis to jointly develop and commercialize treatments in the fields of migraine and Alzheimer’s disease. The collaboration focuses on investigational Amgen drugs in the migraine field, including erenumab and AMG 301, currently in Phase I development. In April 2017, the collaboration was expanded to include co-commercialization of erenumab in the US. For the migraine program, Amgen retains exclusive commercialization rights in Japan, and Novartis has exclusive commercialization rights in Europe, Canada, and the rest of world. Also, the companies are partnering in the development and commercialization of a beta-secretase (BACE) inhibitor program to treat Alzheimer’s disease. The oral therapy CNP520 , currently in Phase II/III for Alzheimer’s disease is the lead molecule and further compounds from both companies’ preclinical BACE inhibitor programs may be considered as follow-on molecules.

Source: Amgen

EMA Advisory Committee Recommends AstraZeneca’s Psoriasis Drug
AtraZeneca reports that its partner LEO Pharma has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the approval of brodalumab for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

Brodalumab is a fully human monoclonal antibody that selectively targets the IL-17 receptor. By binding to the receptor, brodalumab blocks the biological activity of several pro-inflammatory IL-17 cytokines, which are important in psoriasis, according to information from the company.

In July 2016, AstraZeneca announced an agreement granting LEO Pharma, a specialist in dermatology, exclusive rights to develop and commercialize brodalumab in Europe. The drug was approved by the US Food and Drug Administration under the brand name Siliq in February 2017, and the drug was approved by the Japanese Pharmaceuticals and Medical Devices Agency in 2016.

The CHMP’s positive opinion on brodalumab will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU). The final decision is applicable to all EU and European Economic Area countries (Iceland, Liechtenstein, and Norway).

Source: AstraZeneca

EMA Advisory Committee Recommends Additional Use for Novartis’ Lung Cancer Drug
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of expanding the use of Novartis’ Zykadia (ceritinib) to include the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive.

The CHMP recommendation will now be reviewed by the European Commission (EC), which holds the authority to approve medicines for the European Union (EU). The EC typically follows the CHMP recommendation and typically issues an approval decision within two months, applicable to all 28 EU member states plus Iceland, Lichtenstein, and Norway. Earlier this year, the US Food and Drug Administration (FDA) granted Zykadia breakthrough therapy designation for first-line treatment of patients with ALK-positive NSCLC with metastases to the brain. The application for first-line use of Zykadia is under priority review by the FDA.

Zykadia is an oral, selective inhibitor of ALK, a gene that can fuse with others to form an abnormal “fusion protein” that promotes the development and growth of certain tumors in cancers, including NSCLC, according to information from Novartis. In the US, the drug is approved for treating patients with ALK-positive metastatic NSCLC, who have progressed on or are intolerant to crizotinib, the active ingredient in Pfizer’s cancer drug, Xalkori.

Source: Novartis

FDA Accepts sBLA for Merck & Co.’s Immuno-oncology Drug Keytruda for Additional Cancer Indication
The US Food and Drug Administration has accepted for review a supplemental biologics license application (sBLA) for Merck & Co.’s Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, seeking approval for treatment of patients with recurrent or advanced gastric or gastroesophageal junction adenocarcinoma who have already received two or more lines of chemotherapy. The FDA granted priority review with a target action date of Sept. 22, 2017. Keytruda is one of Merck’s top-selling drugs with 2016 global sales of $1.4 billion.

Keytruda is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. It is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Keytruda is also approved in the US for treating unresectable or metastatic melanoma, metastatic non-small cell lung cancer, recurrent or metastatic head and neck squamous cell carcinoma, refractory classical Hodgkin lymphoma, and certain forms of bladder cancer.

Source: Merck & Co.

EMA Advisory Committee Recommends Additional Use for Merck & Co.’s HIV Drug
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Merck & Co. Inc.’s Isentress (raltegravir) 600-mg film-coated tablets, in combination with other anti-retroviral medicinal products, for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg.The recommendation will now be reviewed by the European Commission for marketing authorization in the European Union. A decision on approval is expected in the second half of 2017.

The once daily formulation of Isentress is currently under review in the US by the Food and Drug Administration.

Isentress is an integrase inhibitor and is now approved for the treatment of HIV-1 infection in adult and pediatric patients aged four weeks and older and weighing at least 3 kg as part of combination HIV therapy. It works by inhibiting the insertion of HIV-1 DNA into human DNA by the integrase enzyme and has demonstrated antiviral activity, according to information from the company. Inhibiting integrase from performing this function limits the ability of the virus to replicate and infect new cells.

The drug is approved as part of combination therapy in 112 countries for treatment of HIV-1 infection in adults. Isentress chewable tablets, in combination therapy, for use in children and adolescents with HIV-1 aged two years and older has been approved for use in 69 countries, and Isentress granules for oral suspension for infants at least four weeks of age is approved for use in 33 countries.

Source: Merck & Co.

EMA Begins Review for New Use of BMS’ Leukemia Drug
The European Medicines Agency (EMA) has validated its grouped Type II variation/extension of application for Bristol-Myers Squibb’s (BMS) Sprycel (dasatinib) to treat children and adolescents aged 1 year to 18 years with chronic phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) and to include the powder for oral suspension. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process. Sprycel was one of BMS’ top-selling product with 2016 global sales of $1.8 billion. 

Sprycel was first approved by theUS Food and Drug Administration in 2006 for the treatment of adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) who are resistant or intolerant to prior therapy, including imatinib, the active ingredient in Novartis’ Gleevec. At that time, Sprycel was also approved for adults with Ph+ acute lymphoblastic leukemia (ALL) who are resistant or intolerant to prior therapy. Sprycel is approved and marketed worldwide for these indications in more than 60 countries. Sprycel is also an FDA-approved treatment for adults with newly diagnosed CP Ph+ CML (since October 2010). Sprycel received accelerated FDA approval for this indication. Additional country approvals for this indication total more than 50.

Source: Bristol-Myers Squibb

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