PHARMACY

FDA approves Janssen’s Stelara to treat Crohn’s disease

BY David Salazar
SILVER SPRING, Md. — Janssen Biotech announced Monday that the Food and Drug Administration had approved its Stelara (ustekinumab) to treat moderately to severely active Crohn’s disease.  
 
It is now indicated for adults with Crohn’s disease who have failed or were intolerant to corticosteroid or immunomodulator treatments, but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant of one or more TNF blocker treatment. 
 
“Crohn's disease is a complex condition to treat, and not all therapies work for every patient,” study investigator and chief of gastroenterology at UC San Diego School of Medicine Dr. William J. Sandborn said. “The FDA approval of Stelara represents an important advancement in treating patients with Crohn's disease, as this therapy offers an alternate mechanism of action to induce and maintain clinical remission over time. Based on the results of the clinical development program, Stelara has the potential to benefit many adults living with Crohn's disease.”
 
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FDA approves Humira biosimilar Amjevita from Amgen

BY David Salazar
SILVER SPRING, Md. — The Food and Drug Administration has approved Amgen’s Amjevita (adalimumab-atto), a biosimilar of AbbVie’s Amgen (adalimumab) and the fourth U.S. biosimilar, the company announced Friday. The drug — Amgen’s first biosimilar — is indicated to treat seven inflammatory conditions, among them moderate to severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and moderate to severe chronic plaque psoriasis. 
 
"Approval of Amjevita is an exciting accomplishment as it marks a new chapter in Amgen's story of being a leader in biotechnology,” Amgen’s EVP research and development Dr. Sean Harper said. “In addition, Amjevita holds the potential to offer patients with chronic inflammatory diseases an additional treatment option.”
 
Like Humira, Amjevita contains a boxed warning about increased risk of serious infections leading to hospitalization or death, the FDA said. It also notes that lymphoma and other malignancies, some of them fatal, have been reported in children and adolescent patients treated with adalimumab products. 
 
“This is the fourth FDA-approved biosimilar. The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions,” FDA Center for Drug Evaluation and Research director Dr. Janet Woodcock said. 
 
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McKesson’s Pharmaserv 7.5 enhances pharmacy services

BY Michael Johnsen

MOON TOWNSHIP, Pa. — McKesson Pharmacy Systems on Friday released Pharmaserv version 7.5 for general availability. The centerpiece of this new release is the integration of the Clinical Programs Solution – McKesson’s proprietary clinical services platform – into the workflow of the pharmacy management system.

“The addition of the Clinical Programs Solution to Pharmaserv will offer significant, immediate benefits for pharmacies,” stated Jamie Gramz, senior director of product management, McKesson Pharmacy Systems. “Expanding the ability to improve patient care through clinical services is a key area of focus for the future of retail pharmacies, and Pharmaserv 7.5 empowers our customers to efficiently pursue these types of clinical opportunities.”

Clinical Programs Solution allows information to automatically synchronize with Pharmaserv to help identify programs for patients with specific disease states. The integration identifies and captures opportunities within workflow, enabling the pharmacy staff to intervene directly in a medication regimen or use the task-based queue to follow up on opportunities at a designated or more convenient time. CPS provides Pharmaserv customers with easy-to-use tools to build their own custom programs for the different types of clinical services they want to offer, including programs for diabetes, vaccinations and over-the-counter recommendations.

In one use case, Adrienne Cervone, owner of Beaver Health Mart, Beaver, Pa., created a “Statins for Diabetes” program to identify diabetic patients over 65 years old not currently on a statin. After CPS identified the patients, Cervone followed up with the physician to recommend an add-on prescription for the appropriate dose of statin. Such customized programs can improve patient care, strengthen relationships with providers, and help address Star Rating quality measures.

“I was able to identify candidate patients, add statins on four of those patients, and then I went to green on my top 20% in EQuIPP, probably over those patients,” Cervone said.                                                                      

Another major component of the Clinical Programs Solution includes the ability to interface with third-party applications. These applications provide support for patient medication adherence, specialty medication management and Medication Therapy Management opportunities. The integration of such programs will simplify the management of clinical services offered by the pharmacy by tying them into workflow and using CPS as a single point of reference for clinical opportunities.

Pharmaserv 7.5 includes several other noteworthy enhancements, including real-time translation of drug administration instructions into 17 languages through an interface with RxTran; tracking of pseudoephedrine sales through a new point of sale payment processor, Cayan; stock bottle scanning of NDC bar codes when entering new prescriptions; and the ability to view prior authorization messages on the main Claims Adjudication Module screen.

“We’re excited to offer this new release of Pharmaserv because it offers so many beneficial enhancements to our customers,” said Gramz. “We understand that medication adherence, patient counseling, and patient safety are core areas of concern for pharmacies today. This new version of Pharmaserv provides valuable solutions for each one of those concerns.”
 

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