Major Pharma Advances: EU Approvals, Vaccine Progress, and Breakthrough Clinical Results

Johnson & Johnson has received approval from the European Union (EU) for nipocalimab (Imaavy), a fully human FcRn blocking monoclonal antibody, as an adjunct to standard treatment for generalized myasthenia gravis (MGg).

This approval is based on data from the pivotal Phase 3 Vivacity-MG3 study, which showed that people who received nipocalimab in combination with standard treatment had superior control compared to those who received placebo in combination with standard treatment over 24 weeks.

Patients who entered the open-label extension phase of VivacityMG3 continued treatment with nipocalimab and maintained improvements up to 20 weeks of follow-up , demonstrating sustained disease control over a prolonged period of time. Safety and tolerability were consistent with other nipocalimab studies.

Sanofi has announced positive results for its NVX-COV2705 vaccine in the Compare study

Sanofi has announced that NVX-COV2705 (Nuxavoid), its non-mRNA protein COVID-19 vaccine, demonstrated lower systemic reactogenicity compared to mRNA-1283 (mNexspike) across all prespecified endpoints in the Compare study.

This was a randomized, double-blind study involving 1,000 adults in the United States. The side effects were less severe and shorter in duration compared to mNexspike.

Furthermore, the frequency of severe systemic symptoms that prevent people from carrying out their normal daily activities was reduced by 50% . It affected fewer than one in ten of its recipients.

Novartis’ malaria treatment receives WHO prequalification

Novartis has announced that the World Health Organization (WHO) has given prequalification to artemether-lumefanterine (Coartem Baby) indicated for newborns and small infants weighing between 2 and 5 kilograms.

Prequalification is a process managed by the WHO to assess the quality, safety, and effectiveness of treatments for diseases such as malaria, HIV/AIDS, and tuberculosis.

The results of the prequalification process , including the lists of prequalified products, are used by the United Nations and other procurement agencies to guide public sector funding and purchasing decisions.

MSD receives EU approval for its combination of pembrolizumab with paclitaxel with or without bevacizumab

MSD has announced that treatment with pembrolizumab (Keytruda) in combination with paclitaxel, with or without bevacizumab, has been approved in the European Union (EU) for the treatment of platinum-resistant primary epithelial ovarian , fallopian tube or peritoneal carcinoma in adults.

This approval is based on the results of the phase 3 Keynote-B96 trial in which pembrolizumab plus paclitaxel, with or without bevacizumab, demonstrated a statistically significant and clinically relevant improvement in progression-free survival (PFS) by reducing disease or death by 28%.

It also demonstrated a statistically significant and clinically relevant improvement in overall survival in patients with platinum-resistant recurrent ovarian cancer.

Sanofi receives CHMP approval for BTK inhibitor tolebrutinib

Sanofi receives approval from the Committee for Medicinal Products for Human Use (CHMP) for tolebrutinib (Cenrifki) for the treatment of secondary progressive multiple sclerosis (SPMS) without relapse in the last two years.

It is an oral inhibitor of Bruton’s tyrosine kinase with brain penetration capacity, specifically designed to act on persistent neuroinflammation, a key factor in the progression of disability in multiple sclerosis.

The positive opinion is based on the phase 3 Hercules study in relapse-free SPMS, with supporting data from the phase 3 Gemini 1 and Gemini 2 studies in relapsing multiple sclerosis (RMS).

The safety profile of tolebrutizimab has been consistent throughout the clinical program. The most frequent adverse events were COVID-19 and upper respiratory tract infections. Significant elevations in liver enzymes were also observed. Drug-induced liver injury (DILI) is an identified safety risk for tolebrutizimab.

Roche presents results from two studies evaluating fenebrutinib and satralizumab in patients with relapsing multiple sclerosis

Roche has presented results from the Fenhance 1 and 2 studies, which evaluates fenebrutinib , as well as the Meteoroid study, which evaluates satralizumab .

Fenebrutinib has met its primary endpoint . This investigational non-covalent Bruton’s tyrosine kinase (BTK) inhibitor reduced the annualized relapse rate by 51.5% in the first study and 58.5% in the second study compared in patients with relapsing multiple sclerosis (RMS) over 96 weeks.

Treatment with satralizumab, meanwhile, reduced the risk of relapse by 68% compared to placebo in adults and adolescents with Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (Mogad). It also reduced the annualized relapse rate by 66%.

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