Likelihood of Approval and Phase Transition Success Rate Model – Human Papillomavirus (Virus Like Particle, 9-valent) Vaccine in Human Papillomavirus Infections
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This report provides you with the data that allows you to track and predict the specific likelihood of approval (LOA) and phase transition success rate (PTSR) of a drug using GlobalData’s proprietary machine learning algorithms developed using over 10 years of historical data.


Human Papillomavirus (Virus Like Particle, 9-valent) Vaccine in Human Papillomavirus Infections Drug Details:
Human papillomavirus [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (9-valent) vaccine (Gardasil 9/ Silgard 9) is a non-infectious recombinant 9-valent vaccine prepared from the purified virus-like particles, formulated as suspension for intramuscular route of administration. Gardasil 9 is indicated for active immunisation of individuals from the age of 9 years against premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by HPV types and genital warts (Condyloma acuminata) caused by specific HPV types. Gardasil 9 indicated following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 : cervical intraepithelial neoplasia (CIN) grade 2/3 and cervical adenocarcinoma in situ (AIS), cervical intraepithelial neoplasia (CIN) grade 1, vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3, vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3, anal intraepithelial neoplasia (AIN) grades 1, 2, and 3, indicated in boys 9 through 15 years of age for the prevention of the following diseases: anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58, genital warts (condyloma acuminata) caused by HPV types 6 and 11 And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 : anal intraepithelial neoplasia (AIN) grades 1, 2, and 3. Gardasil 9 is also indicated for use in males 16 through 26 years of age, for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58, precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58, and genital warts caused by HPV types 6 and 11. Gardasil 9 is approved to include a 2-dose regimen for individuals 9 through 14 years of age, and for the prevention of human papillomavirus (HPV) associated cancers including oropharyngeal cancer, head and neck cancers caused by vaccine-type HPV in females and males 9 through 45 years of age.The vaccine candidate is under development for the prevention human papillomavirus associated cancer including anal dysplasia, penile cancer and human papillomavirus infections. The drug candidate is administered through intramuscular route. It is a new molecular entity (NME).
Report Coverage
The data is segmented by drug name per indication and shows the current likelihood of approval for the drug compared to the indication benchmark and the industry benchmark.
The Likelihood of Approval data is updated regularly based on events that take place which impact the clinical development process and regulatory considerations. GlobalData’s proprietary machine learning models consider these events in real time, to produce quantitative changes to the LOA and PTSR along with qualitative reasoning why the likelihood of approval has changed.
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Reasons to Buy
- Precise Likelihood of Approval and Phase Transition Success Rates: Our machine learning and proprietary models provide accurate predictions, helping you gauge the potential success of a drug in the regulatory process.
- Competitive Strategy Planning: Access information on LOA and PTSR for competitors’ drugs, allowing you to plan your clinical development, commercialisation and marketing strategies
- Event-driven Updates: Track event-driven changes in LOA and PTSR benchmarked against indication LOA/PTSR. Get the latest insights to adapt your strategies promptly!
- Well-informed Investment Decisions: This data helps you navigate the dynamic landscape of drug development and regulatory considerations.
Scope
- Drug Details: Drug name, Drug type, Intervention type
- Administration Pathway
- Therapeutic Areas
- Key Manufacturers
- Drug Development Status
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