Prabotulinumtoxin A biosimilar by Daewoong Pharmaceutical for Sleep Disorders: Likelihood of Approval

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Prabotulinumtoxin A biosimilar is under clinical development by Daewoong Pharmaceutical and currently in Phase II for Sleep Disorders. According to GlobalData, Phase II drugs for Sleep Disorders have a 49% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Prabotulinumtoxin A biosimilar’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Prabotulinumtoxin A biosimilar overview

Prabotulinumtoxin A (Nabota) is a biosimilar of clostridium botulinum A toxin. It is a protein produced by the bacterium Clostridium botulinum. It is formulated as injection powder solution for intradermal and intramuscular route of administration. Nabota is indicated for muscle spasticity, and blepharospasm (eyelid spasms).

It is under development for the treatment of blepharospasm, sleep bruxism, gastroparesis and spasmodic torticollis (cervical dystonia), unspecified musculoskeletal disorders (benign masseteric hypertrophy), cervical dystonia and as preventive treatment of post-traumatic stress disorder (PTSD). The drug candidate is an injectable 900 kDa purified botulinum toxin type A complex. It is administered through intramuscular and intradermal routes as a powder for solution.

It was under development for the treatment of episodic, chronic migraine.

Daewoong Pharmaceutical overview

Daewoong Pharmaceutical, a subsidiary of Daewoong Co Ltd, is a manufacturer and distributor of prescription drugs in South Korea. It offers prescription drugs, quasi drugs, healthcare products and APIs. The company produces products in the form of tablets, capsules, ointments, injections, liquids, and sprays. It offers products for conditions such as bone and joint diseases, cardiovascular diseases, central nervous system diseases, circulatory system, dermatological, gastrointestinal, and respiratory system remedies. It also carries out the development and commercialization of products through in-licensing, co-marketing and co-promotion. The company operates in Japan, the US, Canada, Switzerland, Germany, besides Indonesia, China, Vietnam, Israel, Thailand, and India in Asia. Daewoong Pharmaceutical is headquartered in Seoul, South Korea.

For a complete picture of Prabotulinumtoxin A biosimilar’s drug-specific PTSR and LoA scores, buy the report here.

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.

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