New Osteoporosis Drug Launched in Japan

For our readers in Japan good news has arrived over the approval of teriparatide, known in the U.S. as Forteo ®, for the treatment of high-risk patients with osteoporosis.   The drug is being marketed as TeriboneTM and is available as a 56.5 µg subcutaneous (sub q) weekly injection.

For those familiar with or who have taken Forteo for low t-scores and high-risk for fracture, this news is welcome for those living in Japan.   The company marketing this is Asahi Kasei Pharma, and the indication for this treatment is a weekly injection of teriparatide (Teribone), unlike our administration of Forteo of daily sub q injections.

In Japan_, it is estimated that more than 11 million people suffer from osteoporosis, including those not receiving treatment, and the number is increasing as the population ages.   Since osteoporosis carries an increased risk of vertebral and femoral fracture, with a high probability of resulting in confinement to bed, the implementation of effective measures against osteoporosis is an important social issue._

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Teribone, like Forteo is a man-made form of human parathyroid hormone that works to reduce fractures, stimulate bone growth and is considered an anabolic, which acts much differently than the current antiresorptives that only slow bone loss, like Fosamax ®, Reclast ®, Boniva ®, Actonel ® and Atelvia ®.

The above antiresorptives - aka bisphosphonates - come with many serious side effects and many patients are very reluctant to take them.   Teribone has its own side effects, but they are quite different than what we see in bisphosphonates, and teriparatide has a treatment limit.   One of the reasons we limit the use of teriparatide is the study done on rats that acquired osteosarcoma (bone cancer) when given 3-60 times the human dose for their entire lives and while their bones were still growing.   Teriparatide can not be given to humans whose bones are still growing and the dose strength is much lower with a limit for lifetime use.   Teribone will have a limited treatment length of up to 72 weeks at the once a week injection, which varies from our indication for Forteo of a life-time limit of 2 years.   Teribone is also a larger single weekly dose, compared to the 20 micrograms per day of Forteo.

Side Effects:

  1. Nausea
  2. Joint aches
  3. Pain
  4. Dizziness
  5. Rapid heart beat

Contraindications:

  1. Shouldn't take if you have high blood calcium levels
  2. Paget's disease
  3. Bone cancer
  4. Trouble injecting yourself
  5. Kidney stones
  6. Radiation therapy
  7. Pregnant or thinking of becoming pregnant
  8. Breast-feeding

Researchers testing Teribone demonstrated that, with weekly subcutaneous injections for 72 weeks, Teribone decreased the risk of developing new vertebral fracture by 78.6% compared to placebo treatment.   Efficacy is obtained by reducing fractures, increasing bone strength, bone mass and bone quality.

In addition to this injectable form of teriparatide marketed as Teribone, Asahi Kasei Pharma is also launching a transdermal patch form of teriparatide in conjunction with Zosano Pharma Inc.

Sources:


  1. Asahi Kasei Corporation: November 25, 2011 Press Release Launch of Teribone Osteoporosis Drug in Japan      http://www.asahi-kasei.co.jp/asahi/en/news/2011/e111125.html
  1. Side Effects listing: Prescribing information Eli Lily Medguide http://pi.lilly.com/us/forteo-medguide.pdf