FDA approves Sylvant (siltuximab) to treat patients with multicentric Castleman’s disease
SILVER SPRING, Md. — The Food and Drug Administration on Wednesday approved Sylvant (siltuximab) to treat patients with multicentric Castleman’s disease, a rare disorder similar to lymphoma (cancer of the lymph nodes).
MCD causes an abnormal overgrowth of immune cells in lymph nodes and related tissues in the body. The disease usually affects adults who often suffer from fever, night sweats, weight loss and weakness or fatigue because their body’s immune system is weakened and cannot fight infections.
Sylvant is an injection that works by blocking a protein that stimulates abnormal growth of immune cells. It is intended for patients with MCD who do not have HIV or human herpes virus 8 (HHV-8).
“Sylvant is the first FDA-approved drug to treat patients with MCD,” stated Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval demonstrates the FDA’s commitment to approving drugs for rare diseases.”
The FDA reviewed Sylvant under its priority review program, which provides an expedited review for drugs that demonstrate the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition. Sylvant was also granted orphan product designation because it is intended to treat a rare disease or condition.
Sylvant’s safety and effectiveness were evaluated in a clinical trial of 79 participants with MCD who were HIV and HHV-8 negative. Participants were randomly assigned to receive a combination of Sylvant and best supportive care, or placebo and best supportive care. Results showed 34% of participants treated with Sylvant and best supportive care experienced tumor response, while no participant treated with placebo and best supportive care did.
Common side effects include itchy skin (pruritis), weight gain, rash, increased levels of uric acid in the blood and upper respiratory tract infection.
Sylvant is marketed by Janssen Biotech, based in Horsham, Pa.
Safeway Q1 sales up 1%
PLEASANTON, Calif. — Safeway on Wednesday afternoon posted sales of $8.3 billion in the first quarter of 2014, representing an increase of 1%. The slight uptick in sales was primarily attributed to an identical-store sales (excluding fuel) increase of 1.8%, partly offset by lower fuel sales in 2014.
The identical-store sales (excluding fuel) increase of 1.8% consists of a 1% increase in price per item and a 0.8% increase in volume. Safeway's share of sales in all outlet channels increased slightly, and sales to its most loyal households improved during the quarter.
"We are working diligently to close the merger with Albertsons by the fourth quarter," stated Robert Edwards, Safeway president & CEO. "While sales met plan in the first quarter, income was slightly below plan, in part as a result of inflation in produce, meat and pharmacy that was not fully passed along for competitive reasons," he said. "In the second quarter of 2014, identical-stores sales are currently running well above 2%, and we expect to pass along most of the inflation we are experiencing. In addition, the direct and indirect cost initiatives we are implementing are expected to improve profitability in the second half of 2014."
Safeway continues to drive sales momentum through its center of store remodels, as well as merchandising premium, Hispanic and Asian products to meet local demographic needs, Edwards reported. "In addition, our sales of organic and natural products continue to grow at a rapid pace, with our private label brands O Organics and Open Nature growing approximately two times faster than the rest of the market."
NACDS applauds bills to advance better care for chronically ill patients
ARLINGTON, Va. — Bipartisan legislation has been introduced in the U.S. Senate and U.S. House of Representatives to advance better care for Medicare patients with chronic conditions. The bills have received the support of the National Association of Chain Drug Stores, which sent letters to Senate Finance Committee chairman Ron Wyden, D-Ore., U.S. Sen. Johnny Isakson, R-Ga., and U.S. Reps. Erik Paulsen, R-Minn., and Peter Welch, D-Vt.
Specifically, the “Better Care, Lower Costs Act” (S. 1932 and H.R. 3890) would amend the Social Security Act to establish a Medicare Better Care Program to provide integrated care for Medicare patients with chronic conditions.
“Your legislation will promote accountability and better care management for chronically ill patients and provide coordinated services under Parts A, B and D, while recognizing that pharmacists and pharmacy services have great potential to improve care for patients with chronic health conditions,” NACDS stated in the letter.
Better Care Programs provide a coordinated care approach for patients with chronic conditions to help them manage their health.
“We support the concept of using Better Care Programs to provide fully-integrated medical care for people with chronic health conditions,” the letter stated.
The letter also emphasized the increasing role of pharmacy care and services in improving patient health and making healthcare more affordable, and the recognition by lawmakers of that increased role.
“As the demand for healthcare services continues to grow, pharmacists have expanded their role in healthcare delivery, partnering with physicians, nurses, and other healthcare providers to meet their patients’ needs. By providing services that allow patients to take their medications more effectively and by providing preventive services, pharmacists help patients avoid more costly forms of care down the line,” NACDS stated in the letter.
“Pharmacy services improve quality of life and healthcare affordability. We are happy that the effectiveness of pharmacists in delivering patient care is resonating with policymakers,” NACDS concluded in the letter.