Novartis, Amgen Lead Pipeline News

A roundup of the latest pipeline news, including from the pharmaceutical majors, featuring news from Novartis and Amgen as well as Seattle Genetics.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday June 14, 2017 to Tuesday June 20, 2017.

FDA Accepts Novartis’ NDA for Generic of GSK’s Respiratory Drug
The US Food and Drug Administration (FDA) has accepted an abbreviated new drug application (ANDA) from Sandoz, the generics arm of Novartis, for a fluticasone propionate/salmeterol combination product, as a substitutable generic version of GlaxoSmithKline’s (GSK) Advair Diskus. Advair is GSK’s top-selling product with 2016 sales of £3.5 billion ($4.5 billion).

If approved, the product will treat asthma in patients four years and older, in addition to providing maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease.

In 2010, Sandoz acquired Oriel Therapeutics to gain additional expertise in the development of orally inhaled medicines.

Sandoz’s generic version would face competition from other products. In April 2017, Teva simultaneously launched AirDuo RespiClick (fluticasone propionate and salmeterol) inhalation powder and its authorized generic, fluticasone propionate and salmeterol inhalation powder (multidose dry powder inhaler), for treating asthma. AirDuo and its authorized generic are fixed-dose combination asthma therapies containing an inhaled corticosteroid (ICS) and a long-acting beta2-adrenergic agonist (LABA), the same active ingredients in GSK’s Advair Diskus (fluticasone propionate and salmeterol), but administered in Teva’s proprietary RespiClick inhaler.

The FDA approved Teva’s AirDuo in January 2017 on the 505(b)(2) pathway, making it not directly interchangeable with Advair. However, Teva’s strategy of launching, at the same time, an authorized generic version of its branded AirDuo RespiClick allows it to offer a lower-price alternative while still having a branded product differentiated enough from Advair that it can use an above-generic price.

Another would-be competitor to GSK’s Advair is Mylan, which filed an ANDA for fluticasone propionate and salmeterol inhalation powder, its generic version to Advair Diskus, to the FDA in December 2015. However, Mylan’s ANDA filing received a Complete Response Letter by the FDA in March 2017, which is now under review by Mylan.

Source: Novartis

FDA Accepts Amgen’s sBLA for New Use for Amgen’s Cancer Drug Xgeva
The US Food and Drug Administration (FDA) has accepted the supplemental biologics license application for Amgen’s Xgeva (denosumab) that seeks to expand the currently approved indication for the prevention of fractures and other skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma.

Xgeva is a human monoclonal antibody that binds to and neutralizes Rank ligand, a protein used in the formation, function, and survival of osteoclasts, which break down bone. Xgeva is now indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors, but is not indicated for the prevention of skeletal-related events in patients with multiple myeloma.

The FDA has set a Prescription Drug User Fee Act action date for February 3, 2018.

Source: Amgen

Seattle Genetics Ends Phase III Development of Cancer Drug
Seattle Genetics, a biopharmaceutical company, is discontinuing a Phase III clinical trial of vadastuximab talirine in frontline older acute myeloid leukemia patients.

Seattle Genetics took this action following consultation with the Independent Data Monitoring Committee (IDMC) and after reviewing unblinded data on June 16, 2017. The data indicated a higher rate of deaths, including fatal infections in the vadastuximab talirine-containing arm versus the control arm of the trial. Seattle Genetics is suspending patient enrollment and treatment in all of its vadastuximab talirine clinical trials, including the ongoing Phase I/II clinical trial in frontline high risk myelodysplastic syndrome.

Seattle Genetics said it will closely review the data and consult with the US Food and Drug Administration to determine future plans for the vadastuximab talirine development program.

Source: Seattle Genetics

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