Today, we’re catching up after a long weekend on news involving Amgen and Replimune, as well as updates from Sanofi, Roche, Eisai and Biogen that you may have missed.
Amgen on Tuesday said it will invest more than $600 million in a new center for science and innovation at its global headquarters in Thousand Oaks, California. The multidisciplinary center will have “advanced automation and digital capabilities,” and focus on developing new therapies for serious diseases. Construction will begin in the third quarter of this year. The announcement follows Amgen’s $900 million expansion in Ohio, and a $1 billion construction of a manufacturing plant in Holly Springs, North Carolina. In its statement, the company cited recently renewed U.S. corporate tax cuts as a tailwind for its domestic investment. — Delilah Alvarado
Replimune, which controversially had its melanoma drug rejected by the Food and Drug Administration in July, on Tuesday said it has scheduled a meeting with the agency to discuss the complete response letter. The biotechnology company has also submitted a “briefing book” it says addresses the FDA’s concern. Should the agency ultimately refuse to approve Replimune's drug again, company CEO Sushil Patel said further development, including a Phase 3 confirmatory study, “will not be viable.” — Ned Pagliarulo
The FDA has approved the first BTK inhibitor for immune thrombocytopenia, clearing Sanofi’s rilzabrutinib on Friday. The drug, which Sanofi will sell as Wayrilz, is OK’d for adults with persistent or chronic immune thrombocytopenia who did not have a positive response to prior treatment. The disorder causes the immune system to mistakenly attack and destroy platelets, which can lead to bruising and bleeding. The oral drug was approved based on positive Phase 3 trial results, and is being studied across other rare disorders. — Delilah Alvarado
Roche and partner Alnylam Pharmaceuticals plan this year to begin a large cardiovascular outcomes study of their experimental blood pressure drug zilbesiran. They expect to enroll around 11,000 people with uncontrolled hypertension in the study, which will test twice-yearly dosing of zilebesiran versus placebo. The drug, which blocks production of angiotensinogen via RNA interference, was tested in three Phase 2 trials. Data from the latter was presented over the weekend at this year's European Society of Cardiology Congress, showing treatment helped reduce office systolic blood pressure at month three. The study did not meet its formal primary endpoint, however. — Ned Pagliarulo
The FDA on Friday approved a new autoinjector formulation of Eisai and Biogen’s Alzheimer's disease drug Leqembi. The autoinjector, which the companies will market as Leqembi Iqlik for maintenance dosing, can be administered in about 15 seconds, compared to the roughly one hour needed for the intravenous infusion formulation. After 18 months of IV treatment, patients can switch to receive Leqembi via weekly autoinjector doses, for which Eisai and Biogen will charge $375 per pen at list price. The approval came a day after the FDA recommended earlier MRI monitoring of patients treated with IV Leqembi to better detect brain swelling. — Ned Pagliarulo
