A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from Shire, Allergan, Pfizer, AstraZeneca and Merck & Co., and Amgen.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, February 21, 2017 to Tuesday, February 27, 2017.

FDA Accepts Shire’s BLA, Grants Priority Review for Angioedema Drug
The US Food and Drug Administration (FDA) has accepted Shire’s biologics license application (BLA) and granted priority review for lanadelumab, an investigational treatment for preventing angioedema attacks in patients 12 years and older with the rare, genetic disorder, hereditary angioedema (HAE).

Lanadelumab is an investigational fully human monoclonal antibody that provides a new mechanism of action inhibiting plasma kallikrein for the prevention of HAE attacks, according to information from Shire.

The FDA grants priority review designation to drugs that have the potential to provide significant improvements in the safety or effectiveness for the treatment, diagnosis, or prevention of a disease. Drugs with priority review designation have an accelerated review target of eight months instead of the standard of 12 months. The FDA is expected to provide a decision on lanadelumab by August 26, 2018, based on the Prescription Drug User Fee Act V action date.

Source: Shire

FDA Accepts Allergan’s sNDA for Birth Control Drug Liletta
The US Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) from Allergan and Medicines360, a San Francisco, California-headquartered nonprofit women’s health pharmaceutical company, for expanded use of the companies’ birth-control drug, Liletta (levonorgestrel-releasing intrauterine system).

Specifically, the application seeks to extend Liletta’s duration of use for preventing pregnancy from up to four years to up to five years.

Allergan and Medicines360 partnered to launch Liletta, which first was approved in February 2015, and received an additional FDA approval in January 2016 for its single-handed inserter. In August 2017, the duration of use of Liletta for preventing pregnancy was approved for up to four years.

Source: Allergan

EMA Advisory Committee Recommends Two of Pfizer’s Hematology Medicines
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended that two Pfizer hematology medicines be granted marketing authorizations in the European Union (EU): Mylotarg (gemtuzumab ozogamicin), an antibody drug conjugate (ADC), and Bosulif (bosutinib).

The CHMP granted a positive opinion to Mylotarg in combination with daunorubicin and cytarabine for treating patients age 15 years and above with previously untreated CD33-positive acute myeloid leukemia (AML), except acute promyelocytic leukemia. The CHMP recommended Bosulif for treating adults with newly diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). The CHMP’s opinions for both medicines will now be reviewed separately by the European Commission.

Mylotarg is an ADC comprised of the cytotoxic agent, calicheamicin, attached to a monoclonal antibody targeting CD33, an antigen expressed on the surface of myeloblasts in more than 90% of AML patients, according to Pfizer. When Mylotarg binds to the CD33 antigen on the cell surface, it is absorbed into the cell, and calicheamicin is released causing cell death, according to Pfizer.

Mylotarg was originally approved by the US Food and Drug Administration (FDA) in 2000 under an accelerated approval program for use as a single agent in first-relapse patients with CD33-positive AML who were 60 years or older. In 2010, Pfizer voluntarily withdrew Mylotarg after a confirmatory Phase III trial at that time did not show a clinical benefit, and the fatal induction toxicity rate was significantly higher in the Mylotarg arm of the clinical trial. It was later approved by the FDA in September 2017 for treating adults with newly diagnosed CD33-positive AML, and in adults and children two years and older with relapsed or refractory CD33-positive AML.

Bosulif is an oral, once-daily, tyrosine kinase inhibitor, which inhibits the Bcr-Abl kinase that promotes CML; it is also an inhibitor of Src-family kinases. Bosulif was first approved in September 2012 in the US for treating adult patients with chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy.

Pfizer and Avillion, a London, UK-based company focused on increasing research and development output, signed a development agreement in 2014 to conduct the trial evaluating Bosulif for adults with newly diagnosed chronic phase Ph+ CML. Under the agreement, Avillion provided funding for the trial to generate the clinical data used to support this application and other potential regulatory filings for marketing authorization for Bosulif as first-line treatment for patients with chronic phase Ph+ CML. Pfizer retains all rights to commercialize Bosulif globally.

Source: Pfizer

EMA Advisory Committee Recommends AstraZeneca, Merck & Co.’s Ovarian Cancer Drug Lynparza
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended AstraZeneca’s and Merck & Co.’s Lynparza (olaparib) tablets (300 mg, twice daily) as a maintenance therapy for treating patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer regardless of the patients’ BRCA mutation status.

Lynparza, a poly ADP-ribose polymerase inhibitor, was initially licensed as a capsule formulation. The new tablet formulation will reduce dosing from eight capsules twice daily to two tablets twice daily. Lynparza is available in nearly 60 countries for treating ovarian cancer. In January 2018, Lynparza was approved by the US Food and Drug Administration for use in metastatic breast cancer.

In July 2017, AstraZeneca and Merck & Co., entered into a global strategic oncology collaboration to co-develop and co-commercialize AstraZeneca’s Lynparza for multiple cancer types. The companies are jointly developing Lynparza and selumetinib, the active ingredient in another AstraZeneca cancer drug, in combination with other potential new medicines and as a monotherapy. Independently, the companies will develop Lynparza and selumetinib in combination with their respective programmed death-ligand 1 (PD-L1) and PD-1 medicines.

Source: AstraZeneca and Merck & Co.

EMA Advisory Committee Recommends Expanded Use of Amgen’s Cancer Drug Xgeva
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended to expand the current indication for Amgen’s Xgeva (denosumab) of preventing skeletal-related events in patients with bone metastases from solid tumors to cover skeletal-related events in patients with multiple myeloma.

Xgeva is a fully human monoclonal antibody that binds to and neutralizes RANK ligand (RANKL), a protein used in the formation, function, and survival of osteoclasts, cells which break down bone, thereby inhibiting osteoclast-mediated bone destruction, according to information from Amgen. In January 2018, the US Food and Drug Administration approved the supplemental biologics license application for Xgeva to expand the approved indication for preventing skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma. Amgen says additional regulatory applications for Xgeva for preventing skeletal-related events in patients with multiple myeloma are underway and have been submitted to health authorities worldwide.

Following the CHMP positive opinion, the European Commission will consider the expanded use of  Xgeva to cover the multiple myeloma patient population. Norway, Iceland and Liechtenstein will take corresponding decisions on the basis of the decision of the European Commission.

Source: Amgen