GlaxoSmithKline, Bristol-Myers Squibb Lead Pipeline News
A roundup of the latest pipeline news, including from the pharmaceutical majors, featuring news from GlaxoSmithKline and Bristol-Myers Squibb as well as Eli Lilly and Company.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday June 28, 2017 to Tuesday July 11, 2017.
BMS Gets Priority Review for New Use for Leukemia Sprycel
The US Food and Drug Administration (FDA) has accepted Bristol-Myers Squibb’s supplemental new drug application (sNDA) to include an indication for the leukemia drug, Sprycel (dasatinib), to treat children with Philadelphia chromosome-positive chronic phase, chronic myeloid leukemia as well as a powder for oral suspension formulation of Sprycel.
The application is under priority review with an action date of November 9, 2017). The drug had revenues of $494 million in 2016.
Sprycel first received FDA approval in 2006 for the treatment of adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia in chronic phase who are resistant or intolerant to prior therapy including imatinib.
Source: Bristol-Myers Squibb
Lilly Gets FDA Priority Review for Breast Cancer Drug
The US Food and Drug Administration (FDA) has accepted the new drug application (NDA) for Eli Lilly and Company’s cancer drug, abemaciclib, a CDK4 and 6 small-molecule inhibitor, and has given the NDA a priority-review designation.
The NDA includes the company’s submission of abemaciclib for two indications: abemaciclib monotherapy for patients with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who had prior endocrine therapy and chemotherapy for metastatic disease; and for abemaciclib in combination with fulvestrant in women with HR+, HER2- advanced breast cancer who had disease progression following endocrine therapy.
In 2015, the FDA granted abemaciclib breakthrough therapy designation.
Lilly is working closely with the FDA and anticipates agency action on this application in the first quarter of 2018. In addition, Lilly intends to submit abemaciclib to European regulators in the third quarter of 2017 and to Japanese regulators before the end of 2017.
Source: Eli Lilly and Company
EMA Advisory Committee Recommends Several Drugs for Approval
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended for approval the following drugs:
- A new dosing for GlaxoSmithKline’s (GSK) four-dose vial presentation of its Synflorix pneumococcal vaccine. Synflorix is indicated for active immunization against invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks up to 5 years of age. Synflorix is licensed in more than 125 countries and is used in more than 53 national or regional immunization programs.
- Merck KGaA’s cladribine tablets (proposed tradename Mavenclad) for treating relapsing forms of multiple sclerosis in patients with high disease activity.
Source: Merck KGaA
- An additional use for AstraZeneca’s Faslodex(fulvestrant) for treating hormone receptor-positive (HR+), locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy, or with disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on anti-oestrogen therapy.
- An additional use of the label in the European Union (EU) for Novo Nordisk’s Victoza (liraglutide up to 1.8 mg) in people with Type 2 diabetes, at high risk of major cardiovascular events. The CHMP has recommended an update of the indication for Victoza to reflect both glycemic control and cardiovascular events as integral parts of Type two diabetes treatment. Victoza was approved in the EU in 2009 and is commercially available in more than 95 countries. In the US, Victoza was approved in 2010 as an adjunct to diet and exercise to improve blood glucose control in adults with Type 2 diabetes. Novo Nordisk expects to receive the European Commission decision for the Victoza label update in the third quarter of 2017.
Source: Novo Nordisk
- Abbvie’s Maviret (glecaprevir/pibrentasvir), an investigational, pan-genotypic treatment for adults with chronic hepatitis C virus (HCV) infection. If approved, Maviret will be a once-daily, ribavirin-free, 8-week option for patients without cirrhosis and who are new to treatment across all genotypes, who comprise the majority of people living with HCV, according to AbbVie. The European Commission expects a final decision in expected the third quarter of 2017.
- Marketing authorization of a pediatric formulation of Amgen’s Mimpara (cinacalcet) for the treatment of secondary hyperparathyroidism (HPT) in children aged three years and older with end‑stage renal disease on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy. Mimpara was originally approved in the EU in 2004. The therapy is also approved in the EU for the reduction of hypercalcemia in adult patients with parathyroid carcinoma and with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.