This week, the European Commission granted marketing authorization to the expanded use of AbbVie’s (ABBV Quick QuoteABBV - Free Report) Rinvoq and AstraZeneca’s (AZN Quick QuoteAZN - Free Report) blockbuster cancer drugs, Imfinzi and Daiichi-Sankyo partnered, Enhertu. Novartis (NVS Quick QuoteNVS - Free Report) announced plans to invest $23 billion over the next five years to boost manufacturing, R&D and technology in the United States amid the tariff threats.

Here's a recap of the week’s most important stories.

European Commission Approves AbbVie’s Rinvoq for 8^th Indication

The European Commission (“EC”) granted marketing approval to AbbVie’s Rinvoq for treating giant cell arteritis (“GCA”), an autoimmune disease that causes inflammation of the large arteries. Rinvoq is the first JAK inhibitor approved in the European Union (“EU”) for this indication, based on data from the phase III SELECT-GCA study. An application seeking approval of Rinvoq for GCA is also under review in the United States.

GCA marks the eighth approved indication for Rinvoq, which is already approved for seven immune-mediated inflammatory diseases in several countries, including the United States and the EU. It is being studied in late-stage studies for some others like systemic lupus erythematosus, hidradenitis suppurativa vitiligo and Takayasu arteritis.

EU Approval for the Expanded Use of AZN’s Key Cancer Drugs

AstraZeneca announced that the EC has approved the expanded use of Imfinzi in combination with chemotherapy for treating adults with resectable non-small cell lung cancer (NSCLC) with no known EGFR mutations or ALK rearrangements. In this regimen, Imfinzi, in combination with neoadjuvant chemotherapy, is administered before surgery and as adjuvant monotherapy after surgery.

The approval in the EU was expected as the Committee for Medicinal Products for Human Use had recommended the approval of Imfinzi for the given indication last month. This approval was based on data from the phase III AEGEAN study. Imfinzi was approved for a similar indication in the United States in August last year.

The EC also approved the expanded use of AstraZeneca and partner Daiichi Sankyo’s Enhertu in breast cancer. The regulatory body has now approved Enhertu as a monotherapy for treating metastatic HR-positive, HER2-low or HER2-ultralow breast cancer in adult patients who have received at least one endocrine therapy in the metastatic setting and are not considered suitable for endocrine therapy as the next line of treatment in the EU.

The latest nod in the EU expands the approved indication of Enhertu in HER2-low metastatic breast cancer to include use in an earlier disease setting as well as in a broader patient population that includes HER2-ultralow. The latest approval is based on data from the DESTINY-Breast06 study. Enhertu was approved for HR-positive, HER2-low or HER2-ultralow metastatic breast cancer in the United States in January.

Novartis to Invest $23B to Boost U.S. Manufacturing & R&D Presence

After J&J and Lilly, Novartis is the latest drugmaker to announce plans to expand its U.S.-based manufacturing and R&D footprint. Novartis said it would invest $23 billion in 10 facilities, including seven brand new facilities, over the next five years to boost production in the United States. This will bring Novartis’ total U.S. investments to nearly $50 billion. Novartis believes the manufacturing expansion will allow it to produce 100% of its key medicines end-to-end in the country, which is much higher than its current ability.  This expansion of its current manufacturing, research and technology presence will create nearly 1,000 new jobs at Novartis and approximately 4,000 additional U.S. jobs.

With Trump planning to impose tariffs on pharmaceutical imports, drugmakers are looking to ramp up U.S. investments to boost domestic production, which had shifted to lower-cost markets outside the United States for years.

AbbVie, Novartis and AstraZeneca carry a Zacks Rank #3 (Hold) each.

The NYSE ARCA Pharmaceutical Index has declined 9.8% in the past five trading sessions.

Large Cap Pharmaceuticals Industry 5YR % Return

 

Large Cap Pharmaceuticals Industry 5YR % Return

Here’s how the eight major stocks performed in the previous five trading sessions.

Image Source: Zacks Investment Research

In the last five trading sessions, all the stocks were in the red with AbbVie declining the most (13.6%).

In the past six months, all the stocks were in the red with Novo Nordisk declining the most (48.3%).

(See the last pharma stock roundup here: FDA Nod to SNY, AZN, NVS & JNJ Talc Suits Failure)

What's Next in the Pharma World?

Watch this space for regular pipeline and regulatory updates next week.