This week, the FDA approved Sanofi’s SNY hemophilia therapy, fitusiran, Novartis’ NVS Vanrafia for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) and the expanded use of AstraZeneca’s AZN blockbuster cancer drug, Imfinzi. J&J’s JNJ bankruptcy strategy to settle talc lawsuits failed for the third time. The European Commission approved Pfizer’s PFE respiratory syncytial virus (RSV) vaccine, Abrysvo, for use in adults aged 18 through 59 years.

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

Texas Court Rejects J&J’s Bankruptcy Attempt to End Talc Suits

A bankruptcy court in Texas rejected J&J’s proposed bankruptcy plan to settle claims related to its talc lawsuits for the third time. In September, J&J, via a subsidiary called Red River Talc, filed for voluntary bankruptcy in the Southern District of Texas after it received the support of around 83% of current claimants for the proposed bankruptcy plan, which was above the 75% required by the U.S. bankruptcy code.

Red River also increased its settlement commitment by $1.75 billion to approximately $8 billion. However, the U.S. Bankruptcy Court for the Southern District of Texas said that the vote of claimants on the proposal was flawed. Instead of appealing against the Texas court’s decision, J&J will go back to the traditional tort system to fight the lawsuits individually. The company will reverse approximately $7 billion previously reserved for settlements.

FDA Approves SNY’s Hemophilia Therapy Fitusiran

The FDA granted approval to Sanofi’s fitusiran for the prophylactic treatment of people with hemophilia A or B with or without inhibitors. Fitusiran, which will be marketed by the name of Qfitlia, becomes the first therapy approved in the United States for treating hemophilia A or B with or without inhibitors. The approval is based on data from the ATLAS phase III studies. Sanofi in-licensed global rights to fitusiran from Alnylam in 2018. Qfitlia allows low-frequency treatment, subcutaneous administration and low-volume injections compared to currently available therapies.

The FDA granted orphan drug designation to Sanofi’s pipeline candidate, rilzabrutinib, for the treatment of two rare diseases, warm autoimmune hemolytic anemia (wAIHA) and IgG4-related disease (IgG4-RD). Rilzabrutinib is currently being evaluated in phase II studies for both wAIHA and IgG4-RD. Rilzabrutinib is currently under regulatory review in the United States and EU for immune thrombocytopenia. 

FDA Approves Novartis’ IgAN Therapy Vanrafia

The FDA also granted accelerated approval to Novartis’ once daily oral drug, Vanrafia (atrasentan), for the reduction of proteinuria, a major risk factor in patients with IgAN, a progressive, rare kidney disease. The accelerated approval from the FDA was based on a prespecified interim analysis of the late-stage ALIGN study, which measured the reduction of proteinuria at 36 weeks compared to placebo. However, the data has not yet demonstrated that Vanrafia slows kidney function decline in patients with IgAN. Continued approval of Vanrafia is contingent on the demonstration of clinical benefit in the ongoing ALIGN study. The study continues to evaluate if Vanrafia slows disease progression as measured by the estimated glomerular filtration rate decline at week 136. eGFR data from the study is expected next year.

FDA Approves AZN’s Imfinzi for Muscle-Invasive Bladder Cancer

The FDA granted approval for the expanded use of AstraZeneca’s blockbuster drug, Imfinzi (durvalumab), for treating muscle-invasive bladder cancer that has spread to the muscle wall of the bladder. This is the first approval for Imfinzi (in combination with gemcitabine and cisplatin as a perioperative regimen) in a bladder cancer indication.  The approval was based on data from the phase III NIAGARA study. Regulatory applications seeking approval for Imfinzi for similar use are under review in the EU, Japan and several other countries.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency gave a positive opinion, recommending the approval of Calquence as a combination treatment for first-line mantle cell lymphoma (MCL), a rare and typically aggressive form of non-Hodgkin lymphoma.  The regulatory application was based on data from the ECHO phase III study. Calquence, in combination with bendamustine and rituximab, is already approved in the United States and several other countries for the treatment of previously untreated MCL, based on the ECHO study data.

In February, the CHMP had given a positive opinion on Calquence as a monotherapy for the treatment of adult patients with relapsed or refractory MCL. In the EU, Calquence is presently approved for previously untreated chronic lymphocytic leukemia (CLL) and for CLL in patients who have received at least one prior therapy.

Pfizer’s Abrysvo Gets EU Nod for Adults Aged 18-49

The European Commission granted approval for the expanded use of Abrysvo for adults 18 to 59 years for the prevention of RSV-associated lower respiratory tract disease. The approval was based on data from a phase III study called MONeT. Abrysvo was approved for adults aged 18-59 in the United States in October last year. Abrysvo was approved and launched to help protect older adults (aged more than 60), as well as infants, through maternal immunization in the United States, EU and some other countries in 2023.

Pfizer, Novartis, Sanofi and J&J carry a Zacks Rank #3 (Hold) each, while AstraZeneca is a #4 Ranked (Sell) stock.

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

The NYSE ARCA Pharmaceutical Index has declined 1.9% 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, AstraZeneca rose the most (1.4%), while Lilly declined the most (4.0%).

In the past six months, AbbVie has risen the most (6.0%), while Novo Nordisk declined the most (42.4%).

(See the last pharma stock roundup here: PFE’s Final Haleon Stake Sale, AZN, SNY M&A Deals)

What's Next in the Pharma World?

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

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