Ingenol Mebutate
Ingenol Mebutate
Ingenol mebutate, Ingenol-3-angulate or PEP005 is commonly known with the trade name of PICATO of Leo pharmaceuticals. It is a topical gel used under strict regulations to treat Actinic Keratosis (AK) for a short duration therapy and to lower the recurrence rate of AK compared to the available drugs (Soyer H.P,Prowl T.W,Jemec G.B.E. 2015).This gel has been approved by The U.S. Food and Drug Administration (FDA),Therapeutic Goods Administration (TGA) and European Medicines Agency (EMA) (U.S Food and Drug Administration n.d.) It has a dual mechanism of action; those are rapid lesion necrosis and specific neutrophil-mediated, antibody-dependent cellular cytotoxicity. …show more content…
(National Center for Biotechnology Information n.d.)
Drug Discovery
Ingenol mebutate is the active ingredient in the sap of the plant Euphorbia peplus in Australia.It is a diterpene ester, it is the active form of the drug and not considered as a prodrug. It is obtained from the aerial parts of the plants followed by extraction and purification. This plant has being used in traditional herbal remedy to a variety of ailments, including skin cancers and keratosis (Nielsch U;Fuhrmann U;Jaroch S. 2004) .Component extraction research of this plant resulted in the identification of a number of diterpene esters which all were capable of producing an inflammation reaction, of which ingenol mebutate was identified as the cytotoxic compound. (Rizk AM, Hammouda FM, Evans FJ …show more content…
The complete clinical clearance of more than 50% of lesions after a mean follow-up time of 15 months supported further clinical development of ingenol mebutate (Berman 2012)
Drug Development
In the process of drug development, lead identification of 25 compounds with similar bioactivity was identified. (National Center for Biotechnology Information n.d.)
Regulatory Approvals
Ingenol Mebutate is identified as a New Molecular Entity (NME) by Center of Drug Evaluation and Research (CDER) of FDA in 23/01/2012 under the FDA application No (NDA) 202833 .It is reviewed as a Standard Review Drug by FDA. (U.S Food and Drug Administration n.d.)
Pharmocovigilance studies
Post marketing cases submitted to the FDA Adverse Event Reporting System (FAERS) for Picato
Ingenol mebutate, Ingenol-3-angulate or PEP005 is commonly known with the trade name of PICATO of Leo pharmaceuticals. It is a topical gel used under strict regulations to treat Actinic Keratosis (AK) for a short duration therapy and to lower the recurrence rate of AK compared to the available drugs (Soyer H.P,Prowl T.W,Jemec G.B.E. 2015).This gel has been approved by The U.S. Food and Drug Administration (FDA),Therapeutic Goods Administration (TGA) and European Medicines Agency (EMA) (U.S Food and Drug Administration n.d.) It has a dual mechanism of action; those are rapid lesion necrosis and specific neutrophil-mediated, antibody-dependent cellular cytotoxicity. …show more content…
(National Center for Biotechnology Information n.d.)
Drug Discovery
Ingenol mebutate is the active ingredient in the sap of the plant Euphorbia peplus in Australia.It is a diterpene ester, it is the active form of the drug and not considered as a prodrug. It is obtained from the aerial parts of the plants followed by extraction and purification. This plant has being used in traditional herbal remedy to a variety of ailments, including skin cancers and keratosis (Nielsch U;Fuhrmann U;Jaroch S. 2004) .Component extraction research of this plant resulted in the identification of a number of diterpene esters which all were capable of producing an inflammation reaction, of which ingenol mebutate was identified as the cytotoxic compound. (Rizk AM, Hammouda FM, Evans FJ …show more content…
The complete clinical clearance of more than 50% of lesions after a mean follow-up time of 15 months supported further clinical development of ingenol mebutate (Berman 2012)
Drug Development
In the process of drug development, lead identification of 25 compounds with similar bioactivity was identified. (National Center for Biotechnology Information n.d.)
Regulatory Approvals
Ingenol Mebutate is identified as a New Molecular Entity (NME) by Center of Drug Evaluation and Research (CDER) of FDA in 23/01/2012 under the FDA application No (NDA) 202833 .It is reviewed as a Standard Review Drug by FDA. (U.S Food and Drug Administration n.d.)
Pharmocovigilance studies
Post marketing cases submitted to the FDA Adverse Event Reporting System (FAERS) for Picato