imiquimod Cream 5 %

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Comments
DCP approved
Manufacturer #6978

Manufacturer usually replies in 3 days

Imiquimod

Imiquimod acts as an immune response modifier. Imiquimod is a cream prescribed to treat genital warts, Bowen's disease or squamous cell & basal cell carcinoma, secondary to surgery, as well as actinic keratosis. It is sold as a cream for self-application. It's 5% topical the cream is applied to perianal and external genital warts and small superficial basal-cell carcinomas. It cures non-hyperkeratotic and non-hypertrophic actinic keratoses affecting the face or scalp especially in immunocompetent adults when efficacy decreases by the size or number of lesions or when the patient is intolerant or not responding to cryotherapy and other topical treatments. Imiquimod is marketed as Aldara among others. 3M pharmaceuticals got the first FDA approval in 1997 as a treatment for external genital and perianal warts. As of 2015, it is generic and is available worldwide under many brands. Later, 3M was also given FDA approval to market imiquimod as a treatment for superficial basal cell carcinoma in 2004.

Dosage and treatment

Imiquimod has treatment regimes. In using to treat Actinic keratosis, it is applied two or three times a week for 4 to 6x weeks. This can be repeated as necessary after a break of a month. Three weeks before the start of treatment, the scaliest lesions are frozen with liquid nitrogen. In treating Basal cell and intraepidermal carcinoma, it is used five times a week for six weeks. In treating Genital warts, it is applied three times weekly or the 3.75% cream daily for up to 8 weeks. It is recommended to apply it less often if the reaction is excessive, and more often if no reaction occurs. In case of discontinuation, the course can be resumed after 16 weeks.

The price of Imiquimod

In the USA, the consumers have to pay an average retail price of $152.06 for a generic packet of 5% 12 packets of Cream. In the USA, the same supply costs around USD 9.

How does it work?

Imiquimod's actions stimulate innate and acquired immune responses. This ultimately results in inflammatory cell infiltration within the field of drug application. After this, apoptosis of diseased tissue happens. It does not have any direct antiviral activity but acts on the innate and adaptive immune responses both directly and indirectly. In its Direct action mode, it binds to toll-like receptors seven and eight of macrophages, monocytes, and dendritic cells and by induction of apoptosis.

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