Let’s narrow down to five pieces of news this week. One for each day.
Biogen hit headline in March when they halted both Phase 3 trials EMERGE and ENGAGE; This week, their news on reviving the once-abandoned drug aducanumab was on front page again. Their rationale of resurrecting aducanumab is that a small subset of patients given high dose of aducanumab showed 23% of reduction in cognitive decline. However, the ENGAGE trial with similar design gained contradictory results, and Biogen has no explanation of this divergence.
Some experts worry about how long patients would tolerate the high-dose and adverse reactions like brain swelling. To dive into that, you can listen to the STAT Readout Loud episode this week. Despite all controversies, Biogen’s shares jumped more than 40% after releasing the news. Biogen intends to submit a Biologics License Application (BLA) early next year. Now all eyes are on how FDA will respond to the soon coming BLA filing.
Vertex Pharmaceuticals won its fourth drug approval for cystic fibrosis and the drug will be marketed under the brand name Trikafta. Trikafta is a triple combo that can benefit patients with an F508del genetic mutation. Compared with the limited patient population of their earlier drugs, Trikafta is believed to bring hope to 90% of cystic fibrosis patients. The drug costs $311,000 annually.
A federal lawsuit was filed against Sanofi, GlaxoSmithKline, and Boehringer Ingelheim last week. A long term Zantac user accused these drug companies of not fully disclosing the trace amount of carcinogenic N-nitrosodimethylamine (NDMA) in Zantac. Recently, the patient was diagnosed with cancer. Novartis was the first to voluntarily recall the disqualified batches, followed by Dr. Reddy’s Laboratories, Apotex, and Sanofi. GlaxoSmithKline and Teva haven’t taken actions yet.
Fortunately, the FDA announced that some generic alternatives — Pepcid, Tagamet, Nexium, Prevacid, and Prilosec contained no harmful compound NDMA. Also, the FDA released a new testing standard for manufacturers to quantify acceptable NDMA level in ranitidine.
Gilead CAR-T Sales Slow, Renewing Growth Doubts (BioPharma Dive)
Though Yescarta saw little enhanced quarterly performance in 2019 compared with that of 2018, the relatively flat growth casts doubt on Yescarta’s ability to fuel Gilead continuing growth while its hepatitis C business is slowing down rapidly. Besides that, Yescarta faces growing competition like Polivy (polatuzumab vedotin) marketed by Roche. Nevertheless, Gilead expects to see sales boost after they increase reimbursement for patients, improve long term outcomes, and other strategies.
Seattle Genetics’ HER2CLIMB trial is a multinational, randomized Phase 3 trial which enrolled 612 patients with metastatic HER2-positive breast cancer. The group treated with a trio regime — tucatinib+trastuzumab+capecitabine — showed a 46% decrease in the disease progression or death compared with the group treated with trastuzumab+capecitabine only. Patients with brain metastases experienced a 52% decrease in disease progression or death. Overall survival was also improved with a 34% decrease in death.
Tucatinib is a small molecule tyrosine kinase inhibitor specifically targeting HER2, which is overexpressed approximately in one out of every five breast cancers. The drug was added to the pipeline through the acquisition of Cascadian Therapeutics last year. Seattle Genetics plans to file a New Drug Application early next year.