Denosumab

Forecasting Denosumab Introduction Denosumab is a biological product used in the treatment of osteoporosis which is the condition of fragility in bones which have lost tissue due to lack of vitamin D or inadequate calcium. This product is the first RANK inhibitor meaning it prohibited the activity of the protein. (Calkins 2017)The prohibiting of RANK minimizes the failure of bones. Denosumab is given out by a health care professional who injects a dosage of 60mg after every six months. (Green 2010)

Forecasting Denosumab Why is forecasting for any new drug so important? Why for Denosumab? Drug forecasting is a very important and essential process for any drug for multiple reasons: 1. Cost: The drug development is a lengthy and an expensive process. It will aid in the predevelopment process to identify future demand and to identify if it is a worthwhile venture. The future of a company could depend on the success or failure of a new drug in the market. 2. Profitability 3. Market

Denosumab, which inhibits bone resorption by binding to the RANKL, was the first biologic therapy approved to treat osteoporosis [11,12]. A large trial involving women with a BMD T score between −2.5 and −4.0 at the lumbar spine or total hip showed that treatment with denosumab (60 mg administered twice yearly by subcutaneous injection) had a significantly lower risk of fractures than the

balance is altered, resulting in greater bone removal than replacement. This imbalance is seen greatly with advancing age and menopause. With the onset of menopause, the rate of remodeling increases and it increases the risk of fractures. Prolia (denosumab) is a RANK ligand that is approved by the FDA in 2010. Indications • Treatment of postmenopausal women with osteoporosis at high risk for fracture • Treatment to

Forecasting Denosumab “Our job is quite simple,” explained Jennifer Fry, project manager at Oakdale Strategy Group, a strategy consulting firm based in Chicago. It was a cold day in early February 2011, and Fry was meeting with her team. “We’ve been asked to develop a forecast for denosumab for 2015,” she continued. “Our client is one of the world’s largest pharmaceutical firms. The senior executives there are taking a close look at acquiring Amgen and want an outside opinion about denosumab.” Steven

most important of these criteria is increasing BMD and decreasing fracture rates. Increasing BMD is crucial as a BMD within 1.5 standard deviations of the healthy mean strongly decreases fracture rates. The available research on bisphosphonates and denosumab did not provide strong evidence supporting that one medication was more efficacious than the other. In regards to vertebral fractures, both medications were effective in decreasing vertebral fracture rates. None of the studies provided numerical

Knee caps are overrated. Sure, they are useful for covering and protecting your knee joint, but in all honesty why would that be important. Lungs? Important? Oh no they also don’t need to be functioning properly. I much rather be missing a kneecap and have spotted lungs. Which is hilarious because that is exactly what I have. In 2009, I noticed my knee was swollen. It hurt to move or touch it. The doctors kept insisting it was just runner's knee, but it kept swelling and growing. Finally after several

According to Mayo Clinic, “Osteoporosis causes bones to become weak and brittle — so brittle that a fall or even mild stresses like bending over or coughing can cause a fracture. Osteoporosis-related fractures most commonly occur in the hip, wrist or spine” (2014). The issue of osteoporosis is very important due to the fact that it happens to a lot of people all over the world. Although the disorder of the bone occurs in older people, I believe that everyone should learn about osteoporosis before

Zoledronic acid), Raloxifene (Selective estrogen receptor modulators), Calcitonin (hormone decreases bone resorption by inhibiting osteoclast activity), Denosumab, Teriparatid(Parathyroid hormone). The first drug used is alendronate because of its high efficacy in preventing fractures and low cost. If the first line drug failed other bisphosnates or denosumab can be used. Ralaxofeine used as third line drug because it has a risk of developing blood clot diseases, yet it decreases the risk of breast cancer

Osteoporosis is the disease process by which bone remodeling is altered. This alteration is when old bone is insufficiently replaced by new bone (Cosman et al, 2014). New bone growth peaks in the early 20’s and after this age bone mass is lost faster than generated. The lack of new bone replaced can lead to fractures and deformed skeletal architecture. This alteration occurs with menopause, increased age, or long term use of corticosteroids (Cosman et al, 2014) Often the first sign of osteoporosis