Amgen scored the big win for its PCSK9 drug Repatha (evolocumab). The FDA announced Thursday afternoon that it has given Amgen a green light on marketing the PCSK9 cholesterol drug, opening the door to what will likely prove a blockbuster market.
Amgen is likely to start today off with a case of bubbly chilling in the company cafeteria. The FDA has reached its deadline on a marketing decision for the cholesterol drug Repatha (evolocumab), which most likely is on the verge of becoming a major rival to the newly approved Praluent (alirocumab), from Regeneron and Sanofi.
Amgen is paying up to resolve claims that it broke the rules while marketing anemia drug Aranesp and anti-inflammatory blockbuster Enbrel. The company has settled with 48 states for $71 million, marking the latest state-level crackdown on alleged marketing violations in the pharma industry.
Amgen has already paid $762 million to wrap up off-label marketing claims with the feds. Now, 48 states have won another promise to pay from the California-based drugmaker. This time, it's $71 million to resolve allegations that it broke the rules when marketing its anemia drug Aranesp and anti-inflammatory blockbuster Enbrel, two of its best-selling meds.
It isn't too often that drugmakers and journalists go head-to-head in court. But as part of Amgen's latest legal battle, it's asking a federal judge to force a reporter to testify about an article he wrote that prompted a shareholder suit against the company and to spell out how he got information about an abandoned clinical trial.
Medicare has changed its mind on Amgen's Blincyto--and for makers of other expensive cancer drugs, the news is good. The Centers for Medicare and Medicaid Services decided to shell out extra for the blood cancer drug, covering "add-on payments" made to hospitals for new treatments whose costs don't fit into standard lump-sum reimbursements.
India's Dr. Reddy's Laboratories will seek regulatory nods to market Amgen's multiple myeloma drug Kyprolis, immunotherapy Blincyto and PCSK9 inhibitor Repatha in India, the Hyderabad-based company said in a press release, in something of a surprise move by both companies.
Amgen rarely details much on international sales but did give a bit of background on Vectibix in Japan on the July 30 earnings call.
Amgen is only weeks away from an anticipated FDA approval for its PCSK9 cholesterol lowerer. Already approved in Europe, the drug is expected to quickly reap blockbuster sales. The biotech's current portfolio of products, along with cost cuts, have helped set the stage for a big year that could possibly include M&A.
Amgen, long criticized over its appetite for moonshot R&D projects, scaled back its research budget by more than 10% in the second quarter, part of a companywide effort to cut costs while advancing a make-or-break pipeline.