ASV apstiprināta jauna kombinēta terapija pret C hepatītu
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07.11.2014
Amerikāņu kompānija "Johnson&Johnson" 5. novembrī paziņoja, ka ASV Pārtikas un zāļu administrācija (FDA) atļāvusi izmantot preparātu Olysio kombinācijā ar Sovaldi (Gilead), lai ārstētu pacientus, kam ir visizplatītākā vīrusa C hepatīta forma genotips 1. Kā norāda Bloomberg, minētā kombinācija spēj ievērojami samazināt blakņu rašanās risku inficētajiem, jo nav nepieciešamības terapijas laikā izmantot ārstēšanās standarta metodes, tajā skaitā interferonu. Maksa par divpadsmit nedēļas ilgu ārstēšanās kursu ar Olysio saglabājusies tāda pati kā bija iepriekš 66 tūkstoši ASV dolāru.
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Avots: "J&J Wins U.S. Approval for Hepatitis C Combo With Gilead" | http://www.bloomberg.com/news/2014-11-05/j-j-wins-u-s-approval-for-hepatitis-c-combo-with-gilead.html |
Johnson & Johnson (JNJ) won U.S. approval for its hepatitis C drug Olysio to be used in combination with Gilead Sciences Inc. (GILD)s Sovaldi, making it the second all-oral treatment available for the most common form of the virus.
The Food and Drug Administration cleared the once-daily treatment for patients with hepatitis C genotype 1, J&J said yesterday in a statement. The combination allows Olysio to be used without the standard therapies including interferon, an injection that sometimes has flu-like side effects.
The price of hepatitis C treatments has been criticized by insurers and lawmakers since Foster City, California-based Gileads Sovaldi was approved in December with an $84,000 price tag for a full course of treatment. The FDA on Oct. 10 cleared Gileads Harvoni, a once-daily pill that treats patients who have the most common form of the virus without using the older drugs. Harvoni has an estimated cost of $94,500 for 12 weeks.
J&J hasnt changed the $66,000 price for 12 weeks of therapy with Olysio since it was first cleared for use with older medicines in the U.S. a year ago, said Rebecca Tillet, a company spokeswoman. J&J plans to work with insurance companies and other payers to ensure it continues to provide access to patients, she said in a telephone interview.
There are a lot of different patients needs, she said. We think Olysio will play a meaningful role in that mix.
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