Amgen and UCB’s osteoporosis drug romosozumab was rejected by the European Medicines Agency (EMA) due to the potential for cardiovascular risks.

EMA declared that they found some evidence that the drug known as Evenity increases the probability of myocardial infarctions (heart attacks) and strokes occurrence in addition to potentially increasing mortality risk in elderly patients; hence the agency couldn’t get behind approving the osteoporosis medication.

Osteoporosis

15% of 50+ and 70% over 80 may experience this disease evidenced by the weakening of the bones. It is the most common reason for a broken bone in the elderly. Bones that commonly break include the vertebrae and the spine, bones in the forearm and the hip. Typically no symptoms till a bone break, chronic pain and decreased ability to handle basic life activity ensues.

Clearing Regulatory Hurdles

Romosozumab had met regulatory stage gates in many regions including the securing of approval by the FDA in April 2019 as well as comparable agency approvals in Canada, Japan, and South Korea. The approvals were based on the results from clinical trials including FRAME, ARCH and BRIDGE randomized controlled trials evidencing that monthly injections of the monoclonal antibody were superior to placebo or alendronate

Competitor Alendronate (Merck’s Fosamax)

A side note is that alendronate is sold under the name Fosamax by Merck and although millions of women take with no side effect in a strange occurrence some 500 women have reported simultaneous bone fractures and a corresponding lawsuit ensued. As reported in StatNews the spontaneous fractures caused by Fosamax didn’t appear till the drug was marketed for five years. The drug also has been associated with osteonecrosis (bone death) of the jawan incredibly painful ailment exposing jaw bones. Merck agreed to settle for $27.7 million in 1,140 lawsuits associated with the individuals who developed this condition. Fosamax litigation is not done.

Disappointment but Resolve

David M. Reese, MD, executive vice president of research and development of Amgen told the press that “We are disappointed by the committee’s opinion and continue to believe that Evenity has a positive benefit: risk profile.” He noted, “Amgen and UCB remain committed to working with regulatory authorities around the world to bring Evenity to patients and physicians who need additional treatment options for osteoporosis.” 

Appeal

The EMA offers a 15-day appeal period and Amgen and UCB are planning to pursue.

What Medications are Commonly Used for Osteoporosis

Often bisphosphonates are the most commonly prescribed medication for osteoporosis. These medications include:

  •         Alendronate (Fosamax by Merck)
  •         Risedronate (Actonel/Sanofi)
  •         Ibandronate (Boniva/Roche)
  •         Zoledronic acid (Reclast/Novartis)

It is important to note that other key activities to address osteoporosis includes A) exercise B) nutrition C) cease smoking and D) limit alcohol.

Source: Amgen

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