This week, companies like Novo Nordisk (NVO - Free Report) and Eli Lilly and Company (LLY - Free Report) were in the news with both providing regulatory updates. While Novo Nordisk gained approval for a new type II diabetes drug, the FDA expanded the label of Lilly’s Taltz.
Recap of the Week’s Most Important Stories
Novo Nordisk Diabetes Drug Gets FDA Nod: Novo Nordisk got a major boost with the FDA approving the company’s new type II diabetes drug, Ozempic. Ozempic, a once-weekly GLP-1 agonist, is approved for use as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus. Approval comes shortly after an FDA advisory panel had voted in favor of approving the drug.
Although Ozempic will enter a highly crowded market, it has been shown to lead to clinically meaningful and statistically significant reductions in HbA1c compared with placebo, Januvia (sitagliptin), Bydureon (exenatide extended-release) and Lantus (insulin glargine U100). Ozempic is also associated with weight loss. Ozempic is expected to enter the market in early 2018 and represents blockbuster potential (Read more: Novo Nordisk's Semaglutide Gets FDA Approval for Diabetes).
Positive Data on J&J and AbbVie’s Imbruvica-Rituxan Combo for WM: Johnson & Johnson (JNJ - Free Report) and partner, AbbVie presented data on a combination of their BTK inhibitor, Imbruvica, and Rituxan for the treatment of both newly and previously-treated patients with Waldenström's macroglobulinemia (“WM”). The primary endpoint of progression-free survival (“PFS”) was achieved in the late-stage study. Imbruvica is approved for different indications including chronic lymphocytic leukemia, previously treated mantle cell lymphoma and WM as well as chronic graft-versus-host-disease (Read more: AbbVie/J&J's Imbruvica Succeeds in Combo Study with Rituxan).
J&J is a Zacks Rank #2 (Buy) stock - you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. The stock has gained 21.5% year to date, compared to the 14.7% rally of the industry it belongs to.
Sanofi Presents Toujeo Head-to-Head Data, Ends c. difficile Vaccine Development: Sanofi (SNY - Free Report) presented positive data on Toujeo from a head-to-head study versus insulin degludec. The effect of Toujeo on blood sugar levels was found to be similar to that of insulin degludec (Read more: Sanofi's Toujeo Meets Key Objective in Head-to-Head Study). Sanofi also announced that it has decided to end the development of its clostridium difficile vaccine based on a planned interim analysis which showed that the chances of the vaccine meeting the primary endpoint in a late-stage study were low.
This is the latest blow for the company’s vaccine segment which is facing issues with its dengue vaccine, Dengvaxia, due to safety concerns. Earlier this week, the Philippines FDA asked the company to suspend the sale/distribution/marketing of Dengvaxia and withdraw it from the market pending compliance with the directives of the agency.
Second Indication Approved for Lilly’s Taltz: Lilly’s Taltz (ixekizumab) gained FDA approval for its second indication with the agency giving its nod for the use of the drug for the treatment of adults with active psoriatic arthritis (PsA). Taltz was initially approved for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Taltz works by specifically targeting IL-17A, a protein that plays a role in driving underlying inflammation in psoriasis (Read more: Lilly's Taltz Gets Approval for Label Expansion in US).
FDA Nod for First Herceptin Biosimilar: The FDA granted approval to Mylan (MYL - Free Report) and Biocon’s biosimilar version of Roche’s (RHHBY - Free Report) blockbuster cancer drug, Herceptin (trastuzumab). We remind investors that earlier this year in July, the FDA’s Oncologic Drugs Advisory Committee (“ODAC”) had voted in favor of approving the biosimilar. Ogivri has been approved for all indications of the reference product, Herceptin, which includes the treatment of HER2-positive breast and gastric cancers.
Large Cap Pharmaceuticals Industry 5YR % Return
The NYSE ARCA Pharmaceutical Index declined 1.6% over the last five trading sessions. Among major stocks, Lilly was up 1.5% while Bristol-Myers declined 2.1%. Over the last six months, Bristol-Myers was up 19.2% while GlaxoSmithKline (GSK - Free Report) declined 18.7% (See the last pharma stock roundup here: Pfizer/Merck KGaA Drug Fails in Study, Teva CEO Announces Changes).
What's Next in the Pharma World?
Watch out for regulatory and pipeline news from pharma stocks. Several companies will be present at the annual meeting of the American Society of Hematology ("ASH") from December 9-12, with data on approved and pipeline drugs.
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