Osteoporosis drug Romosozumab receives marketing approval in Japan

Monoclonal antibody romosozumab gains first-ever marketing approval in Japan for the treatment of osteoporosis in patients at high risk of fracture announced Amgen and UCB in a joint press release. The drug will be known as Evenity in Japan and would be developed by Amgen Astellas BioPharma K.K.–a joint venture between Amgen and Astellas Pharma Inc., headquartered in Tokyo.

Romosozumab has a dual effect on the bone– it works by binding and inhibiting the activity of the protein sclerostin which increases bone formation and decreases bone breakdown.

Japanese people have the longest life expectancy in the world and with that comes the burden of osteoporotic fractures. In Japan, the osteoporotic fracture is the leading cause of disability that requires long term nursing home care.

"The approval of EVENITY in Japan is a significant milestone that reinforces our commitment to bringing effective treatments to the millions of patients who suffer from osteoporosis," said David M. Reese, M.D., executive vice president of Research and Development at Amgen in a news release.

"A patient with a prior osteoporotic fracture is twice as likely to suffer another fracture if left undiagnosed and without appropriate treatment. With this approval, physicians in Japan now have a new medicine to help patients reduce their risk of fracture."

The approval is based on results of two phase 3 clinical trials– FRAME and BRIDGE. The FRActure study in postmenopausal woMen with ostEoporosis (FRAME), included 7,180 postmenopausal women with osteoporosis. The women received romosozumab 210 mg s.c. or placebo once monthly for 12 months, followed by denosumab 60 mg s.c. once every 6 months in both groups for 12 months. The drug significantly increased spine and hip BMD and reduced vertebral and clinical fracture risk.

The BRIDGE study (placeBo-contRolled study evaluating the efficacy anD safety of romosozumab in treatinG mEn with osteoporosis) involved 245 men with osteoporosis (163 romosozumab, 82 placebo) randomized 2:1 to receive either 210 mg romosozumab or placebo subcutaneously once monthly for 12 months. Men on Romosozumab showed a significant bone mineral density (BMD) gains at the lumbar spine, total hip and femoral neck compared to placebo at six and 12 months.

The approval is also significant because FDA rejected Amgen’s initial marketing application for Romosozumab in the US because of cardiovascular side effects of the drug in ARCH trial. The drug is also under regulatory review in Europe.

The Japanese Pharmaceuticals and Medical Devices Agency undertook a thorough review of the safety profile of EVENITY, including the cardiovascular safety findings in the ARCH trial.

Toshio Matsumoto, M.D., Ph.D., emeritus professor of Tokushima University and the advisor of the university's Fujii Memorial Institute of Medical Sciences said in the press release, "Physicians have been waiting for a new therapeutic option. I have great hope that the approval of EVENITY will help reduce the fracture risk for patients in Japan."

"Patients with a prior fracture face the risk of having another fracture and particularly stand to benefit from the option of a new bone-forming agent," he further added.

Meanwhile, During the second review cycle, the US Food and Drug Administration (FDA) Bone, Reproductive, and Urologic Drugs Advisory Committee (BRUDAC) recently voted in favor of approving Amgen and UCB’s romosozumab (EVENITY) In the US for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The committee indicated that the drug benefits for treatment of postmenopausal osteoporosis outweigh its risk.

Press release

Ultrasound revisited–Personalized imaging anywhere, anytime and by anyone

Will personal ultrasound scanners be readily available and accessible as home glucose or blood pressure monitors? It is possible right now with the Butterfly iQ handheld ultrasound wand and an iPhone– recently showcased at the CES 2019 at Las Vegas.

The new FDA cleared, pocket-sized ultrasound ushers in a new era of medical imaging at a fraction of the cost of large in-office machines. Currently, the FDA clearance covers 13 clinical applications, the broadest ever for a single ultrasound transducer.

The technology is currently only available for trained medical professionals, but shortly it may be possible to get an ultrasound examination without leaving the comforts of the home. The Butterfly team is beta testing software that can guide patients to capture the scans correctly and share it with respective healthcare providers in real time.

iQ is equipped with the latest Ultrasound-on-Chip technology™, where a single silicon chip replaces the piezo-electric crystals of the traditional ultrasound machines. The 2D array of 9000 programmable micro-machined sensors eliminate the need of linear, curved or phased probes for different parts of body. A single probe can be used to image different systems of the body including Ob/gyn, cardiology, musculoskeletal, and many others.  Just slather the probe with gel, and it is possible to switch between different examinations easily.

The probe is compatible with many iPhone models including Apple iOS 11.0 or newer. The built-in battery is optimized for 2 hours continuous scanning or 10-hour shift and can be easily recharged by placing it on the wireless charging base. The iQ device is sleek and housed in an anodized aluminum body to withstand fall or temperature variations,

All the data and images are stored on Butterfly cloud and can be accessed from anywhere at any time. HTTPS, TLS 1.2 and AES 256-bit encryption and monitoring ensure that patient’s scan and personal is protected while at rest and at the time of sharing with the colleagues, peer or health providers. Images can be shared as easily as texting. Just open the image, tag the person and send it as a message.

The Ultrasound comes with deep learning-based artificial intelligence applications tightly coupled to the hardware and helps clinicians with both image acquisition and interpretation. As more and more clinicians use the system, the data acquired to improve the neural network models. This, in turn, will enable the less skilled personnel to capture images correctly.

Priced under $2,000, the Butterfly iQ is currently available for purchase in the US, but it can be reserved for purchase in other countries.

Here is a video about working of Butterfly iQ

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Reserve your iQ here

Novel implantable shock absorbing device to relieve pain and delay progression of knee osteoarthritis

Patients with osteoarthritis (OA) could now delay or avoid knee replacement surgery with the help of a new shock absorbing device that can be implanted alongside the knee joint.  The Wexner Medical Center at the Ohio State University becomes the first center in US to implant the CalypsoKnee System to address the pain of the osteoarthritic knee.

Developed by Moximed, a company based in Fremont, California, a prospective, multicentric clinical trial is underway to look at the ability of the device to extend the life of knee joint and enable the patients to lead a pain-free, comfortable life.

The system is put in place under the skin, alongside the medial side of the affected knee through a small incision. The ligaments and bones forming the knee joints are preserved, keeping options open for any future surgical interventions.

With more than 700,000 knee replacement surgeries performed in the U.S. every year, the Calypso Knee System could reverse the trend and delay or avoid the replacement surgery.  

Dr. David Flanigan, an orthopedic surgeon at The Ohio State University Wexner Medical Center who performed the surgery said in a news release, “ It works like a shock absorber to take pressure off the inside of the knee while creating a cushion similar to what cartilage provides in a healthy joint. The hope is that it increases joint functionality, reduces pain and delays a total knee arthroplasty for years or even decades.”

If found successful, it will soon be available as an option to knee replacement for osteoarthritic patients across the country.

The video shows how the system works in our body

Here is a video with more information on the first patient fitted with the system

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Ohio state university press release