Oct 9 Osteoporosis

FDA approves Bonsity for Osteoporosis

Osteoporosis, recognized as one of the most severe global burdens, is the reason behind more than 8.9 million fractures annually, resulting in an osteoporotic fracture every 3 seconds globally.
FDA recently has permitted the new drug application (NDA) for Bonsity (PF708) for the treatment of osteoporosis. Submitted under the regulatory pathway, NDA has been submitted with Forteo (teriparatide injection) as the reference.

FDA recently has permitted the new drug application (NDA) for Bonsity (PF708) for the treatment of osteoporosis. Submitted under the regulatory pathway, NDA has been submitted with Forteo (teriparatide injection) as the reference.

Osteoporosis is a condition that debilitates bones, making them fragile and brittle. It progresses slowly over several years and is often only diagnosed when a minor fall or sudden impact causes a bone fracture.

Bonsity- an affordable alternative

Bonsity, indicated for the treatment of osteoporosis in patients who are at high risk of fractures, is a cost-effective therapy alternative to Forteo, which made the global sales of worth USD 1.6 Billion last year. The approval of Bonsity marks the breakthrough in the Osteoporosis treatment landscape. Pfenex is set to work with its commercialization partner Alvogen to further plan the launch of PF708 in the U.S. Alvogen has exclusive rights to commercialize and manufacture the drug in the EU, certain countries in the Middle East and North Africa (MENA), and the rest of world (ROW) territories.

According to the study conducted by Markus MacGill et al. 2018, osteoporosis currently affects over 53 million people in the United States.

According to the National Osteoporosis Foundation (NOF), 9.9 million Americans suffer from osteoporosis, and an additional 43.1 million people experience low bone density. In the US, two million fractures are attributed to osteoporosis annually, with 432,000 hospital admissions, 2.5 million medical office visits and approximately 180,000 nursing home admissions.

Moreover, as the ageing population increases in the 7MM, the prevalence of osteoporosis is expected to rise as well, ultimately resulting in higher market revenue.

Osteoporosis Treatment Scenario

Several treatments can be effective in osteoporosis; however, there are several unmet needs in the field of osteoporosis therapy market, comprising treatment of severe osteoporosis, imminent fracture risk, and long-term adherence to the treatment.

The Osteoporosis market revenue is segmented based on drugs classes available for the osteoporosis treatment, such as calcitonin, bisphosphonates, parathyroid hormone therapy (PTH), RANK ligand inhibitors (denosumab), selective estrogen receptor inhibitors (SERMs), and others (estrogen therapy and calcium and vitamin D).

Presently, Amgen’s Xgeva (denosumab) and Prolia (denosumab) are the most looked upon therapy candidates in the Osteoporosis market. 

Xgeva launched commercially in 2010, is primarily marketed in the US and Europe. Xgeva and Prolia contain the same active ingredient, but Prolia has been approved for the different indications, different patient pool, doses and frequencies of administration. Prolia is used essentially for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

Addressing Unmet Needs

To redress the existing issues, current research is focused on the development of bone-forming treatments that may help to address these unmet needs. Two clinical trials have demonstrated the superiority of bone-forming treatments over anti-resorptive in patients with severe osteoporosis implying the need for a more personalized approach in the management of osteoporosis with access to the use of bone-forming therapy in patients. In addition to this, pharmaceutical companies such as Radius Health, Shenzhen Salubris Pharmaceuticals, Amgen Inc and many others are actively working toward the development of potential therapies to fulfil the unmet medical needs of the currently used therapeutics

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