It was discovered at the NIH and was licensed and initially developed by Isis Pharmaceuticals, which subsequently licensed it to Novartis.[2] It was licensed by the FDA for CMV in Aug 1998, and was the first antisense drug that was approved.[3]
Novartis withdrew the marketing authorization in the EU in 2002[4] and in the US in 2006.[5] The drug was withdrawn because while there was a high unmet need for drugs to treat CMV when the drug was initially discovered and developed due to the CMV arising in people with AIDS, the development of HAART dramatically reduced the number of cases of CMV.[2]
[6] It blocks translation of viral mRNA by binding to the complementary sequence of the mRNA transcribed from the template segment of a key CMV gene UL123, which encodes the CMV protein IE2. It was the first antisense antiviral approved by the FDA.[7]
References
^Trevor AJ, Katzung BG, Knuidering-Hall M, Masters S (2012). Katzung & Trevor's Pharmacology (10th ed.). New York: McGraw-Hill Medical Publishing Division. p. 429. ISBN978-0-07-178923-3.
Boyer DS, Cowen SJ, Danis RP, Diamond JG, Fish RH, Goldstein DA, et al. (Vitravene Study Group) (April 2002). "Randomized dose-comparison studies of intravitreous fomivirsen for treatment of cytomegalovirus retinitis that has reactivated or is persistently active despite other therapies in patients with AIDS". American Journal of Ophthalmology. 133 (4): 475–483. doi:10.1016/S0002-9394(02)01326-0. PMID11931781.
Roehr B (October 1998). "Fomivirsen approved for CMV retinitis". Journal of the International Association of Physicians in AIDS Care. 4 (10): 14–16. PMID11365956.
