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

New café in Tokyo houses all robot staff operated remotely by people with disabilities

A new café recently opened in Tokyo is entirely staffed by robots controlled by disabled people remotely. Contrary to the negative side of automation, the café creates jobs for people with severe debilitating conditions like amyotrophic lateral sclerosis (ALS) and spinal cord injuries.

Named Diverse Avatar Working Network) ver.β (DAWN), the café was launched as a joint project between Ory Lab, which develops the robots, Nippon Foundation, and ANA Holdings. The robots serving in the café is OriHime-D–a 4-foot-tall, altogether robot that moves, look around, handles objects, and speak with patrons at Tokyo’s Café. It has a built-in camera, a microphone and a speaker and can remotely control from a smartphone or a PC using the Internet.

Joysticks, blow tubes, or just the movements of the eye easily control the robots to serve coffee and intermingle with the customers. The disabled person or other people who cannot get out of home can earn money comfortably working from home or nursing home.

Currently, there is a staff of 10 people all working remotely from home and get paid 1,000 yen (US$8.80) an hour (a standard wage for part-time work in Japan).

The café was a pilot project for a temporary period and was funded by crowdfunding drive which doubled its funding goal. If the funds are made available on a regular basis, it is hoped that a full-fledged Dawn will open in 2020.

Here is a promo video to give a glimpse of how the concept works

A more realistic demonstration of how a operator controls the robot

A video of the opening ceremony

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Via SoraNews

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Life expectancy will approach the 90-year mark in some countries by 2030, with a persistent female advantage.

courtesy: Pathfinder.gr

Projection of life expectancies is necessary for healthcare policy planning, social services, social security and pension. It also reflects the patterns of health and disease prevailing in the society. A recent paper published online February 21 in Lancet aims to forecast future life expectancy in 35 industrialized countries using the Bayesian model.

Instead of using a single model, the researchers developed an ensemble of 21 forecasting models to  eliminate the uncertainty associated with a single prediction model.

The authors say "Taking model uncertainty into account, we project that life expectancy will increase in these 35 countries with a probability of at least 65% for women and 85% for men, although the increase will vary across countries.”

South Korean women are projected to have the highest life expectancy of more than 86·7 years in 2030 with 90% probability. This is equivalent to current highest life expectancy worldwide. The model also indicated that there is 57% probability that the life expectancy at birth for South Korean women will be higher than 90 years in 2030, "a level that was considered virtually unattainable at the turn of the 21st century by some researchers," the authors write.

Earlier gain in life expectancy in South Korea is due to decrease in infectious disease rate in infant and young adult but the increased longevity of the older groups is due to decrease in death rate from chronic diseases. Other contributing factors include improved nutrition, better access to health care, new medical technologies and control of many infectious diseases. South Korean and Japanese women also have lower BMI, and lower B.P than western counterparts.

South Korean women are followed by women from France, Spain, and Japan and are expected to occupy the top 3 spots in the 2030 list.

Men still lag in this projection with 95% probability of surpassing 80 years in 2030, and a greater than 27% probability that it will surpass 85 years in South Korea, Australia, and Switzerland. Similarly, Men in South Korea and many central European emerging economies like Hungry and Slovenia are going to make large gains in life expectancy by 2030 similar to men in Denmark, Ireland, and a few other western European nations. Currently Australia has the highest life expectancy for men.

In 2010, women had a higher life expectancy than men by 3·9 to 8·5 years. This gap will be narrowed and men will catch up with the female life expectancy by 2030 in every country expect Mexico where female life expectancy is predicted to increase more than male life expectancy.

Most of the projected gains in   life expectancy is due to enhanced longevity in older ages specially women, increasing the aging trends of industrialized countries. In 19 countries, one in two 65-year-old women have another 23 years to live and in other 11 countries 24 years to live.

Similarly, Male life expectancy at age 65 years is projected to surpass 20 years in 22 countries by 2030, “a level that has not been achieved so far” says the authors.

Of the 35 countries studied, the USA, Japan, Sweden, Greece, Macedonia, and Serbia have the lowest projected life expectancy both for men and women.

Currently USA, has the lowest life expectancy at birth than other high income countries and is expected to fall back further in 2030.  USA has the highest Maternal and infant mortality rate, Homicide index and BMI for any high-income country. The life expectancy in US has also stagnated or have declined for few population groups in recent years.  The authors quote "The USA is also the only country in the OECD [Organization for Economic Cooperation and Development] without universal health coverage, and has the largest share of unmet healthcare needs due to financial costs." 

In an accompanying editorial Dr. Santosa write “Forecasting life expectancy at birth and at age 65 years can help governments and health services to make the right investments in health, such as averting deaths due to infectious diseases and reducing maternal and child mortality. Achieving universal health coverage is worthy, plausible, and needs to be continued.”

Full text of the article here.

Full text of the editorial here.