Early results from ongoing study showed that the hepatitis C virus was undetectable by week 4 in 70% of people treated with telaprevir-based combination therapy
- Relative mean improvement in lung function of approximately 17% from baseline compared to placebo achieved by people treated with VX-770; mean absolute improvement from baseline of approximately 10.5% compared to placebo; both measures through 24 and 48 weeks - - Significant improvements in all
-Hepatitis C: Regulatory agencies in U.S., Europe and Canada to provide accelerated reviews of telaprevir applications- -Cystic Fibrosis: First Phase 3 registration data for VX-770 expected in first quarter 2011; potential regulatory submissions in the U.S. and E.U.
-Six-month review date of May 23, 2011 set by FDA- CAMBRIDGE, Mass., Jan 20, 2011 (BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration ( FDA) has accepted the New Drug Application (NDA) for telaprevir and granted the
-Hepatitis C: Submission of New Drug Application complete for telaprevir- -Cystic Fibrosis: First Phase 3 data for VX-770 expected in first quarter 2011- -Additional ongoing trials in HCV, CF, epilepsy and rheumatoid arthritis- -Vertex enters 2011 with cash and cash equivalents position of more
-Two-drug treatment arm of telaprevir and VX-222 alone discontinued- -Study continues with three arms, including all-oral combination of Vertex's lead protease and polymerase inhibitors with ribavirin- -Both of the four-drug treatment arms are fully enrolled; the majority of patients in these arms
-Treatment with VX-770 resulted in improvements in lung function and markers of disease- -There were no discontinuations of treatment due to adverse events- -Late-stage Phase 3 clinical trials for VX-770 ongoing- CAMBRIDGE, Mass., Nov 17, 2010 (BUSINESS WIRE)-- In a study published in this week's
-New treatment arm to evaluate all oral, triple combination regimen of telaprevir, VX-222, and ribavirin- CAMBRIDGE, Mass., Nov 10, 2010 (BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced plans to enroll an additional treatment arm as part of its ongoing Phase 2
<i>-75% of people treated in the Phase 3 ADVANCE study achieved a viral
cure with telaprevir; majority of people treated for a total of 24 weeks-</i>
<br />
<i>-62% of African Americans/Blacks in the ADVANCE study achieved a
viral cure with telaprevir-</i>
<br />
<i>-Low discontinuation rates of all drugs due to adverse events-</i>
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