This week, the FDA granted approval to AbbVie’s (ABBV - Free Report) oral JAK1-selective inhibitor, upadacitinib, to be marketed by the trade name of Rinvoq. Bayer (BAYRY - Free Report) said it is selling its Animal Health business to newly created company, Elanco Health for $7.6 billion. Meanwhile, Glaxo (GSK - Free Report) , Pfizer (PFE - Free Report) and AstraZeneca (AZN - Free Report) provided pipeline and regulatory updates.
Recap of the Week’s Most Important Stories
FDA Approves AbbVie’s Upadacitinib: The FDA granted approval to AbbVie’s oral JAK1-selective inhibitor, upadacitinib, for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA) in patients who experienced inadequate response or intolerance to methotrexate. The drug will be marketed by the trade name of Rinvoq in a 15 mg, once-daily dose. It is expected to be launched in late August.
A similar application is also under review in the EU. The regulatory filings are based on the SELECT phase III program, which evaluated more than 4,000 patients with RA. Please note that AbbVie used a priority review voucher to expedite review of the upadacitinib NDA. Upadacitinib is also being evaluated in several multiple immune-mediated diseases and is expected to lower AbbVie’s dependence on Humira.
Bayer to Sell Animal Health Unit to Elanco: Bayer is divesting its Animal Health business to Elanco Animal Health for $7.6 billion in a cash-and-stock deal. For the purchase, Elanco will pay $5.3 billion in cash to Bayer and $2.3 billion in Elanco stock. The transaction is expected to close in mid-2020. The sale is expected to allow Bayer focus on its life sciences business. Bayer’s Animal Health business is a global leader in the animal health segment, with sales of $1.8 billion in fiscal 2018.
Update from AstraZeneca’s Imfinzi & Farxiga Studies: AstraZeneca’s Imfinzi failed to improve overall survival in the phase III NEPTUNE study, evaluating it for the treatment of stage IV non-small cell lung cancer in previously untreated patients. The primary analysis population of the study was patients with a high tumor mutational burden (TMB). In patients whose blood TMB was 20 or more mutations per megabase, the Imfinzi combo failed to improve overall survival – the primary endpoint – versus standard-of-care (SoC) platinum-based chemotherapy.
Meanwhile, AstraZeneca’s SGLT2 inhibitor, Farxiga met the primary endpoint in a heart failure outcomes study in patients with reduced ejection fraction with and without type-II diabetes. Data from the phase III DAPA-HF study showed that Farxiga, when added to SoC, led to a statistically-significant and clinically-meaningful reduction of cardiovascular death or worsening of heart failure in such patients compared to placebo, thereby meeting the study’s primary endpoint.
AstraZeneca’s partner Fibrogen received regulatory approval in China for roxadustat for the treatment of anemia in chronic kidney disease patients who are not on dialysis. Roxadustat was approved in China in December 2018 for anemia in CKD patients who are on dialysis. China is the first country to grant regulatory approval to the product. A regulatory application looking for approval of roxadustat in the United States is expected to be filed this year.
AstraZeneca also agreed to buy a FDA Priority Review Voucher from a subsidiary of Swedish Orphan Biovitrum AB (publ) (Sobi). On completion of the transaction, AstraZeneca would pay SOBI a purchase consideration of $95 million. The voucher will entitle AstraZeneca to priority review of a candidate of its choice. A priority review would shorten the review period of the candidate from the standard 10 months to six months.
Pfizer Gets FDA’s Priority Review to Expand Label of Xtandi: Pfizer and its Japanese partner Astellas gained FDA’s priority review for a regulatory filing, which was looking to expand the label of its prostate cancer drug, Xtandi to include men with metastatic hormone-sensitive prostate cancer. The regulatory application was based on results of the phase III ARCHES study and an Astellas-supported phase III study, ENZAMET. With the FDA granting priority review, a decision is expected in the fourth quarter of this year.
Pfizer is also investing $500 million for expanding its state-of-the-art gene therapy manufacturing facility in Sanford, NC.
Glaxo Files NDA for Daprodustat in Japan: Glaxo filed a regulatory application in Japan seeking approval for daprodustat for the treatment of renal anemia associated with chronic kidney disease. If approved, daprodustat will be exclusively distributed in Japan by Glaxo’s partner Kyowa Kirin Co., Ltd., following the deal formed between the companies in 2018.
Headline data was presented by Glaxo’s ViiV Healthcare and partner J&J (JNJ - Free Report) from phase III ATLAS-2M study, evaluating eight-week dosing of its long-acting, injectable two-drug HIV regimen of cabotegravir plus rilpivirine. The study evaluated administration of the combo regimen every eight weeks (two months) compared to every four weeks (one month). Data from the study showed that administration of the combo every two months was non-inferior to administration once every month.
Teva Launches EpiPen Jr: Teva (TEVA - Free Report) launched a generic version of Mylan’s popular EpiPen Jr auto-injector (0.15 mg) allergy treatment at a price of $300 for a pack of two. Generic versions of EpiPen Jr for young children along with EpiPen for adults in 0.3 mg and 0.15 mg strengths were approved by the FDA in August to treat life-threatening allergic reactions like anaphylaxis. Teva had launched the generic version of EpiPen auto-injector 0.3 mg for adults in November last year and has launched the version for kids now.
The NYSE ARCA Pharmaceutical Index rose 2.2% in the last five trading sessions.
Here is how the seven major stocks performed in the last five trading sessions.
All the stocks rose last week with Bristol-Myers gaining the most (4.6%).
In the past six months, AstraZeneca has been the biggest gainer (9.4%) while Pfizer lost the most (18.6%).
(See the last pharma stock roundup here: Pipeline/Regulatory Updates From JNJ, LLY, AZN, RHHBY)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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