Tykerb is one of Glaxo's most important new compounds, one which the company hopes will replace sales declines from other top drugs like diabetes treatment Avandia. Tykerb was approved for marketing in the U.S. early last year as a treatment for late-stage breast cancer.
Glaxo received preliminary EU approval for Tyverb to treat breast cancer late last year, but suffered a slight hiccup in the approval process, after it later noticed that patients on the drug were experiencing a higher level of liver-related sided effects. Glaxo and the EU regulatory authorities spent a couple of weeks reviewing this data, then issued a second preliminary approval for the drug in April.
Yesterday's final approval likely means that Glaxo will start marketing Tyverb in the U.K. and Germany soon, while it negotiates reimbursement rates in all five of the largest EU pharmaceutical markets. Sales of Tykerb have gotten off to a good start in the U.S. and elsewhere, with revenue from the drug reaching $102 million last year.
Tykerb competes with compounds like Genentech's
Glaxo's pipeline of cancer treatments is undeservedly underrated compared to oncology behemoths like Genentech, Novartis