PHARMACY

Breast cancer, hepatitis C drugs get FDA approval

BY David Salazar
SILVER SPRING, Md. — The Food and Drug Administration this week has approved two new drugs, Gilead’s hepatitis C treatment Vosevi and Puma Biotechnology’s breast cancer drug Nerlynx. 
 
Nerlynx (neratinib) was approved for patients with early-stage, HER2-poitive breast cancer that is taken after initial treatment to lower the risk of the cancer returning. Roughly 15% of patients with breast cancer have tumors that are HER2-positive, and the National Cancer Institute estimates that 252,710 patients will be diagnosed with breast cancer this year. Nerlynx is indicated for patients who previously have been treated with a regimen that includes trastuzumab. 
 
“HER2-positive breast cancers are aggressive tumors and can spread to other parts of the body, making adjuvant therapy an important part of the treatment plan,” said Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Now, these patients have an option after initial treatment that may help keep the cancer from coming baack.”
 
Gilead’s Vosevi, which received priority review and breakthrough therapy designations from the FDA, is the latest in its line of single-tablet drug regimens. It combines already approved drugs sofosbuvir and velpatasvir with the new drug voxilaprevir. It’s meant to treat patients who have previously been treated with direct-acting sofosbuvir or other drugs that inhibit a protein called NS5A. 
 
“Direct-acting antiviral drugs prevent the virus from multiplying and often cure HCV,” said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Vosevi provides a treatment option for some patients who were not successfully treated with other HCV drugs in the past.”
 
Vosevi is the fourth hepatitis C treatment since 2015 from Gilead, including three single-tablet regimens. The drug comes with a boxed warning about the risk of hepatitis B reinfection among coinfected patients. 
 
“The evolution of Gilead’s portfolio of HCV single-tablet regimens has been driven by our commitment to address previously unmet needs and put the possibility of cure within reach for as many HCV patient populations as possible,” Gilead president and CEO John F. Milligan said. “The approval of Vosevi completes our portfolio by fulfilling the unmet need for an effective regimen for patients who could not be cured, despite prior treatment with certain DAA regimens.”
 

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NASP adds Walgreens, Pfizer and AstraZeneca execs to board

BY David Salazar
WASHINGTON — The National Association of Specialty Pharmacy has added three new members to its board of directors. The organization brought on Walgreens VP federal government relations and U.S. public policy Ed Kaleta; Pfizer's regional president North America for rare disease Tolga Tangular; and AstraZeneca’s executive director of access services Blaine Squires. 
 
“Ed Kaleta, Tolga Tanguler, and Blaine Squires are three experienced, accomplished and seasoned industry veterans, tasked with elevating the practice of specialty pharmacy, promoting the education and certification of pharmacists, and advocating for public policies that ensure patients have appropriate access to specialty medications on behalf of NASP’s multi-stakeholder membership,” NASP executive director Sheila Arquette said. “These three remarkable leaders will be instrumental in helping to ensure patients receive the high-quality, high-touch patient care and support services that are critical to optimally managing and living with complex, life-altering, and often life-threatening diseases.” 
 
Kaleta leads Walgreens’ federal lobbying and public policy activities. Walgreens Specialty Pharmacy offers access to specialty medications, as well as such services as helping patients with medication adherence and connecting patients with financial assistance programs and refill reminder services. Before joining Walgreens, Kaleta was Humana’s Washington office director, helping navigate the company through a health reform legislation effort. He also tripled the size of Humana’s political action committee. He is a founding member of the Coalition for Competitive Pharmaceutical Markets and serves on the boards of Illinois Group and the Business Government Relations Group. 
 
“It’s an honor to serve on the board of an organization dedicated to helping our communities deal with the most devastating of diseases,” Kaleta said. “I believe our pharmacies and pharmacists are the best at what they do, and are vital to the provision and sustainability of healthcare for America. We must ensure that lawmakers understand and recognize their value so that our patients receive the therapy and resources they need to be well.”
 
In his role at Pfizer, Tanguler leads more than 200 colleagues in marketing, sales, access and medical and corporate affairs, as well as a portfolio of six assets to ensure their focus on transforming patients’ lives. One important focus area of his is ensuring that the engagement and experience of patients with rare diseases take precedent in all programs while ensuring the organization is ready for its next phase of scientific breakthroughs. He has more than 15 years’ experience in the pharmaceutical industry, having held leadership roles in such markets as the United States, Japan, Latin America and Africa/Midde East. He was most recently VP global marketing for Eliquis. 
 
“I am honored to be elected to the board of the NASP,” Tolanger said. "I am certain it will provide new opportunities to partner with other industry leaders to raise the standards of patient engagement and ensure access to treatment options for rare disease patients who often do not have other alternatives."
 
Squires heads the AstraZeneca team that oversees the its field reimbursement managers, its internal hub, AZ Access360 and affordability programs. He has previously worked for Johnson & Johnson, Genentech, and has worked with several start-up pharmacy companies. He is a licensed pharmacist in Texas. 
 
"Being part of the NASP team is a tangible way for me to connect my professional work to the broader impact of pharmacy across patient, industry and advocacy arenas," Squires said. "I will support the NASP efforts to continue this important work with positive and significant outcomes." 
 

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Perrigo gets FDA OK for DermOtic Oil generic

BY David Salazar

SILVER SPRING, Md. — The Food and Drug Administration has approved Perrigo’s generic of Hill Dermaceuticals’ DermOtic Oil (fluocinolone acetonide oil, 0.01%) ear drops. The drug is indicated to treat chronic eczematous external otitis in adults and children ages 2 years and older.

 DermOtic Oil had annual U.S. sales of roughly $26 million.

“Upon launch, this will be our fifth new product launched in 2017. These launches include the generic versions of Axiron, Derma-Smoothe/FS Scalp Oil, Derma-Smoothe/FS Body Oil and Hycodan,” Perrigo EVP and president Rx pharmaceuticals John Wesolowski said. “Bringing these new products to market illustrates the Rx team's commitment to providing affordable treatment options for patients in important extended topical categories.”

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