How long did it take for Prolia to get FDA approval

Prolia is a medication used to treat osteoporosis and other bone-related conditions. It is a monoclonal antibody that targets a protein called RANKL, thereby preventing bone resorption. The drug was developed by Amgen Inc. and received FDA approval on June 1, 2010. The journey to FDA approval involved multiple stages and evaluations, lasting several years. Here is a detailed overview of the timeline and key aspects of Prolia's FDA approval process:

1. Preclinical Evaluation:

Prior to conducting clinical trials, preclinical studies were performed using animal models. These studies evaluated the safety, efficacy, and pharmacokinetics of Prolia.

2. Investigational New Drug (IND) Application:

Amgen submitted an IND application to the FDA, providing data from the preclinical studies and outlining the proposed clinical trials. After an initial review, the FDA granted permission to proceed with clinical trials.

3. Phase 1 Clinical Trials:

In Phase 1 trials, Prolia was administered to a small group of healthy volunteers to assess its safety, dosage, and potential side effects. The primary goal was to determine the drug's tolerability and pharmacokinetic profile.

4. Phase 2 Clinical Trials:

Phase 2 trials involved a larger group of patients with osteoporosis or other conditions characterized by bone loss. These trials aimed to further evaluate Prolia's safety and efficacy, as well as identify the appropriate dosage.

5. Phase 3 Clinical Trials:

Phase 3 trials are large-scale studies involving thousands of participants. These trials are designed to provide robust evidence of safety, efficacy, and statistically significant results. Prolia's Phase 3 trials examined various aspects, such as fracture risk reduction and bone mineral density improvement.

6. New Drug Application (NDA) Submission:

After completing the clinical trials, Amgen submitted an NDA to the FDA, including comprehensive data on the drug's safety and efficacy. The application also included details on manufacturing, labeling, and proposed use of Prolia.

7. FDA Review:

The FDA review process involved a thorough evaluation of the submitted data. This included analyzing the clinical trial results, assessing the drug's benefits and risks, and ensuring compliance with regulatory standards.

8. FDA Advisory Committee Meeting:

Prior to making a final decision, the FDA convened an advisory committee meeting where external experts reviewed the data and provided recommendations.

9. FDA Approval:

Based on the extensive review process, the FDA granted approval for Prolia on June 1, 2010. The drug was approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture and for the treatment of bone loss in patients undergoing hormone ablation therapy for prostate or breast cancer.

10. International Pricing:

Pricing for medications can vary across countries due to different healthcare systems and regulatory frameworks. However, it is important to note that specific pricing information is subject to change over time. As of [current year], the approximate annual cost of Prolia in the referenced countries is:

United States: $1,200 - $1,500 per injection (two injections per year)
United Kingdom: £350 - £450 per injection (two injections per year)
South Korea: 2,000,000 - 2,500,000 KRW per injection (two injections per year)
Japan: 120,000 - 150,000 JPY per injection (two injections per year)
China: 10,000 - 15,000 CNY per injection (two injections per year)

11. Key Locations:

The following locations are briefly described for reference within the article:

United States:

The United States is a country in North America. It is the third-largest country by land area and population. The FDA, Food and Drug Administration, is the regulatory authority responsible for drug approval and monitoring within the United States.

United Kingdom:

The United Kingdom, commonly known as the UK, is located in Europe and includes England, Scotland, Wales, and Northern Ireland. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for drug regulation and approval in the UK.

South Korea:

South Korea, officially known as the Republic of Korea, is located in East Asia. The Ministry of Food and Drug Safety (MFDS) governs the approval and regulation of pharmaceuticals in South Korea.

Japan:

Japan is an island country in East Asia, located in the Pacific Ocean. Pharmaceutical and Medical Devices Agency (PMDA) is the regulatory body responsible for drug approval and post-marketing safety surveillance in Japan.

China:

China is a vast country in East Asia. The National Medical Products Administration (NMPA) is the regulatory authority overseeing the approval and monitoring of pharmaceuticals in China.