Dynavax to introduce new hepatitis B vaccine
BERKELEY, Calif. — Dynavax Technologies last week announced that the U.S. Food and Drug Administration has approved Heplisav-B for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Heplisav-B is the first new hepatitis B vaccine in the United States in more than 25 years and the only two-dose hepatitis B vaccine for adults.
"Prevention of hepatitis B in adults through vaccination is more important than ever given the increase in the rate of infections," stated William Schaffner, professor of Preventive Medicine, Vanderbilt University Medical Center. "Too many at-risk adults remain unprotected against this virus. A two-dose schedule with higher rates of protection, along with other strategies, may help us move closer to the goal of eliminating hepatitis B as a public health problem in the United States."
Hepatitis B is an extremely infectious and potentially deadly virus affecting a wide range of adults in the United States. There is no cure for hepatitis B, and infections are on the rise. In 2015, new cases of acute hepatitis B increased by more than 20% nationally.
"HEPLISAV-B is the first FDA-approved product for Dynavax and demonstrates our ability to develop innovative products and progress them from discovery to commercialization," added Eddie Gray, CEO Dynavax. "We expect that [Heplisav-B] will become an essential tool in the public health community's fight to prevent hepatitis B, and we look forward to making Heplisav-B available to clinicians and their adult patients."
Dynavax expects to commercially launch Heplisav-B in the United States in the first quarter of 2018. In preparation for launch, Dynavax has been building commercial infrastructure and optimizing manufacturing processes to meet anticipated demand.
New blood pressure guidelines earn praise from higi
CHICAGO — The American College of Cardiology and American Heart Association on Monday shared new blood pressure standards, and they’ve drawn the praise of population health enablement company higi. The company owns and operates 11,000 health stations across the chain drug, mass, food and club channels.
Under the new guidelines, patients with systolic blood pressure of 130 mmHg or diastolic blood pressure of 80 mmHg are considered to have high blood pressure. Previously, high blood pressure was defined as 140/90 mmHg. This year so far, higi said that 61.5% of its screenings have results in the new hypertensive range.
“The new guidelines released by ACA and AHA are noteworthy — and indicate the vital importance for individuals to know their key biometrics and what it means for their personal health," higi chief medical officer and chief technology officer Dr. Khan Siddiqui said. “Under the new guidelines, two-thirds of higi health screenings are in the hypertensive range – a significant increase from 32% under the previous guidelines. Uniquely positioned to access high-risk populations for hypertension, higi will continue to work with our retail pharmacy and health system partners to motivate individuals to promote lifestyle modifications.”
According to higi, it has seen 43 million individuals use its health stations to check their blood pressure, pulse, body weight and body mass index, which it said is key to helping inform their healthcare management. Patients can share data from higi stations with their physician, pharmacist and other care team members to better manage their health.
FDA approves Abilify with sensor to track ingestion
SILVER SPRING, Md. — The Food and Drug Administration has approved the first pill to contain a digital ingestion tracking system. The Abilify MyCite (aripiprazole with sensor) tablets — a collaboration between Otsuka Pharmaceuticals and Proteus Digital Health — send a message from the pill’s sensor to a wearable patch that links to a mobile app.
“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”
Otsuka said that the pairing of the sensor with the antipsychotic Ability was designed to allow patients with schizophrenia, bipolar I disorder or major depressive disorder to better track their daily medication intake and share that with their care team — which they can control through the linked app. The company said that the product would see an initial limited rollout with a select number of health plans and providers, who will select certain patients, on whose experiences Otsuka said I would base future enhancements.
“This approval marks a potentially transformative juncture in our more than 25 years of experience in the field of mental health therapies,” Otsuka president and representative director Tatsuo Higuchi said. “We remain committed to making a difference for individual patients and their care team by helping address the challenge of objectively measuring medication ingestion. Our rollout of the Abilify MyCite system will be done in phases to obtain, and respond to, feedback from healthcare providers and their patients.”
The sensor is made up of ingredients “found in food,” the company said, noting that it was the size of a grain of sand and activates when the sensor material comes into contact with stomach fluid. The MyCite patch records the date and time of the ingestion, as well as some physiological data. The FDA noted that product is not for use in emergency or real-time situations, as detection could be delayed or not occur. The agency also noted that the product has not shown an ability to improve patient compliance with a treatment regimen.
“The time is right for the category of digital medicines to be available to appropriate patients with serious mental illness,” Proteus Digital health president and CEO Andrew Thompson said. “Consumers already manage important tasks like banking, shopping, and communicating with friends and family by using their smart phones, as they go about their daily lives. With this FDA approval, Otsuka can help enable individuals with serious mental illness to engage with their care team about their treatment plan in a new way.”