Amgen Announces Positive Top-line Results From Phase 3 DAHLIA Study Of ABP 959

RTTNews | 1003 dias atrás
Amgen Announces Positive Top-line Results From Phase 3 DAHLIA Study Of ABP 959

(RTTNews) - Amgen, Inc. (AMGN) announced Tuesday positive top-line results from the DAHLIA study, a randomized, double-blind, active-controlled, two-period crossover Phase 3 study evaluating the efficacy and safety of ABP 959, a biosimilar candidate to SOLIRIS (eculizumab), compared with SOLIRIS in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

The study met its primary endpoints, demonstrating no clinically meaningful differences between ABP 959 and SOLIRIS based on the control of intravascular hemolysis as measured by lactate dehydrogenase (LDH) at week 27 for the parallel comparison, and the time-adjusted area under the effect curve (AUEC) of LDH from week 13 to week 27, from week 39 to week 53, and from week 65 to week 79 for the crossover comparison. The safety and immunogenicity profile of ABP 959 was comparable to SOLIRIS.

ABP 959 is being developed as a biosimilar candidate to SOLIRIS, for the treatment of PNH and other indications. ABP 959 has the same pharmaceutical form, dosage strength, route of administration and dosing regimen as licensed eculizumab in the United States (U.S.) and European Union (EU).

Etiquetas: AMGN
read more
Amgen's Bkemv Approved As First Interchangeable Biosimilar To Soliris

Amgen's Bkemv Approved As First Interchangeable Biosimilar To Soliris

The U.S. Food and Drug Administration has approved Amgen Inc.'s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab), developed by British drug major AstraZeneca's Rare Disease unit Alexion Pharmaceuticals, to treat certain rare diseases. Soliris is a medicine used to treat adults and children with paroxysmal nocturnal haemoglobinuria or PNH...
RTTNews | 357 dias atrás
Australian Market Extends Early Gains In Mid-market

Australian Market Extends Early Gains In Mid-market

The Australian stock market is extending its early gains in mid-market moves on Friday, reversing some of the losses in the previous session, following the mixed cues from Wall Street overnight. The benchmark S&P/ASX 200 is moving to near the 8,400 level, with gains is financial and technology stocks partially offset by weakness in mining and energy stocks.
RTTNews | 46 minutos atrás
Asian Markets Trade Mixed

Asian Markets Trade Mixed

Asian stock markets are trading mixed on Friday, following the mixed cues from Wall Street overnight, as US Treasury yields eased on improved US data and comments from a US Fed official that he still sees a path to interest rate cuts later this year. Concerns about the fiscal impact of the US Republican tax cut bill is weighing on the markets. Asian markets ended mostly lower on Thursday.
RTTNews | 1 h 7 min atrás
Sensex, Nifty Seen Higher At Open

Sensex, Nifty Seen Higher At Open

Indian shares are seen opening a tad higher on Friday as U.S. Treasury yields eased on improved U.S. data and comments from a Federal Reserve official that he still sees a path to interest rate cuts later this year.
RTTNews | 1 h 30 min atrás
Thai Bourse May Extend Losing Streak

Thai Bourse May Extend Losing Streak

The Thai stock market has finished lower in two straight sessions, giving away more than 15 points or 1.2 percent along the way. The Stock Exchange of Thailand now sits just beneath the 1,175-point plateau and it may tick lower again on Friday.
RTTNews | 2 h 7 min atrás