FDA approves Roche’s Hemlibra for hemophilia A without factor VIII inhibitors
Roche has received clearance from the Food and Drug Administration for Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with hemophilia A without factor VIII inhibitors.
Hemlibra is now the only prophylactic treatment for people with hemophilia A with and without factor VIII inhibitors that can be administered subcutaneously, under the skin, and at multiple dosing options — once weekly, every two weeks or every four weeks — the company said.
“Many preventative treatment options for people with hemophilia A without factor VIII inhibitors require intravenous infusions several times a week. Even then, people can still experience bleeds, and there has been a need for more treatment options,”Michael Callaghan, Children’s Hospital of Michigan and Detroit hematologist said in a statement. “The approval of Hemlibra is an important advancement for the entire hemophilia A community, as we now have a new class of medicine for the first time in nearly 20 years. Hemlibra can reduce bleeds, and it offers a new subcutaneous administration once weekly, every two weeks or every four weeks.”
“Today’s approval of Hemlibra reflects our commitment to groundbreaking science and the development of medicines with the potential to redefine the standard of care,” Roche’s chief medical officer and head of global product development Sandra Horning said in a statement. “Hemlibra is now the only FDA-approved medicine for people with hemophilia A with and without factor VIII inhibitors, based on the efficacy and safety profile demonstrated across four pivotal studies. We want to thank the hemophilia community for their partnership in helping us bring this new option to everyone living with hemophilia A.”
Hemlibra was granted Breakthrough Therapy Designation by the FDA for hemophilia A without factor VIII inhibitors. It also was granted Priority Review, a designation given to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a serious disease.
NCPA Convention sees multiple honors awarded
The National Community Pharmacists Association has been busy in Boston. The NCPA Annual Convention, taking place through Oct. 9, already has seen various awards going to community pharmacists.
The organization’s Calvin J. Anthony Lifetime Achievement award was awarded posthumously Saturday to Sharlea Leatherwood of Kansas City, Mo. Leatherwood, a lifelong advocate for community pharmacy, served as NCPA president from 2003 to 2004, making her the organization’s first female president, was president of the NCPA Foundation’s board of trustees and led the nonprofit for eight years. She also owned four community pharmacies and a medical equipment company over the course of her career. She died Oct. 1, and NCPA past president Bob Greenwood accepted the award on behalf of her family. The 2017 award, sponsored by Pharmacists Mutual, was not presented at the 2017 NCPA Annual Convention due to Leatherwood’s illness.
“Sharlea Leatherwood unwaveringly dedicated her time, energy, leadership and passion to the profession of pharmacy and in many ways was a trailblazer for female pharmacists,” said NCPA immediate past president DeAnn Mullins, owner of Mullins Pharmacy in Lynn Haven, Fla. “Her commitment to both independent community pharmacy and the advancement of women in the profession ran long and deep. I can’t think of a more deserving recipient of the NCPA 2017 Lifetime Achievement Award, and we applaud Sharlea for her many lasting contributions to pharmacy as we mourn her recent passing.”
The Calvin J. Anthony Lifetime Achievement Award honors a pharmacist who has dedicated their career to the advancement of the pharmacy profession. Also at the convention, the 2018 Calvin J. Anthony Lifetime Achievement Award was bestowed on Laird Miller of Gainesville, Ga. Miller owns Medical Park Pharmacy, Jennings Pharmacy and Habersham Drug, and is the former chairman and a longtime member of the Georgia Board of Pharmacy. He has been involved in other pharmacy organizations, as well.
“Laird Miller has long been devoted to independent community pharmacy and its patients, including through his efforts to promote community-based prescription drug abuse prevention and his long service on the Georgia Board of Pharmacy,” said NCPA president David Smith.
Also, NCPA honored Jim Spoon, owner of Spoon Drug in Sand Springs, Okla., naming him the NCPA 2018 Willard B. Simmons Independent Pharmacist of the Year. The award, which recognizes leadership and commitment to independent pharmacy and is named for former NCPA executive secretary Willard Simmons, is sponsored by Upsher-Smith.
“Jim has been a tireless advocate for independent community pharmacy over the years, helping shape not only its future but the future of his community through service,” Smith said. “I am proud to honor Jim with this award and recognize him for his work on behalf of community pharmacy in Oklahoma and beyond.”
Also as part of the convention, Ohio pharmacy owner Paul White received this year’s NARD Ownership Award from the NCPA Foundation. The award was presented at the NCPA 2018 Annual Convention.
The NARD Ownership Award recognizes an independent community pharmacist who embraces entrepreneurial spirit through promotion and demonstrated excellence in the field of community pharmacy ownership. The award is inspired by the NARD name, which was for a century the name associated with independent pharmacy.
White founded the first Medicine Center Pharmacy in 1976. In the years following, he grew the business to include four retail pharmacies that included a PCAB-accredited nonsterile compounding lab, a 340B contract pharmacy, a long-term care pharmacy offering strip packaging, and consultant pharmacists for LTC customers.
Additionally, Deborah Bowers, owner of Yorkville Pharmacy in York, S.C., and lead luminary for CPESN South Carolina, is the winner of the 2018 CPESN Luminary-of-the-Year award, sponsored by Upsher-Smith.
CPESN USA, is a clinically integrated, nationwide organization of pharmacy networks organized to advance community-based pharmacy practice.
“I’m honored to be recognized by my peers and thrilled to receive this award,” Bowers said in a statement. “I firmly believe CPESN Networks are the solution for providing quality services for our patients, and sending a unified message to medical-side payers. I’m looking forward to continuing my efforts with CPESN South Carolina.”
Breckenridge gets FDA approval for generic Daliresp for COPD
Breckenridge Pharmaceutical has received the FDA nod for roflumilast tablets, 500 mcg.
The product is the generic of AstraZeneca’s Daliresp tablets.
Roflumilast tablets are a selective phosphodiesterase 4 inhibitor indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
Daliresp had a market value of $211 million for the year ended Aug. 31, 2018, according to industry sales data.
Roflumilast tablets were developed by Ferrer Internacional, S.A.