This week, the FDA approved Sanofi’s SNY Altuviiio, a new class of factor VIII therapy for hemophilia A and granted priority review designation to Pfizer’s PFE regulatory applications seeking approvals for the respiratory syncytial virus (RSV) candidate for maternal immunization and cancer candidate, elranatamab. The regulatory agency also granted Merck MRK and partner Moderna’s MRNA cancer vaccine a Breakthrough Therapy Designation (BTD). The European Commission approved AstraZeneca’s AZN Imfinzi+Imjudo combination for lung & liver cancers in certain patients.
Recap of the Week’s Most Important Stories
FDA Approves Sanofi’s Bleeding Disorder Drug: The FDA granted approval to Sanofi’s novel recombinant factor VIII therapy, efanesoctocog alfa, for the treatment of people with hemophilia A. The drug, which belongs to a new class of factor VIII therapy for hemophilia A, offering significant bleed protection, will be marketed by the name of Altuviiio. The approval was based on data from the XTEND-1 pivotal phase III study. Sanofi has collaborated with Swedish Orphan Biovitrum for the development and commercialization of efanesoctocog alfa. A regulatory application in the EU for the candidate is expected to be filed in the second half of 2023.
FDA’s Breakthrough Tag for Merck/Moderna’s Cancer Vaccine: The FDA granted BTD to Merck and partner Moderna’s investigational personalized cancer vaccine candidate mRNA-4157/V940 in combination with Keytruda for the adjuvant treatment of patients with high-risk melanoma following complete resection. The BTD was based on data from the phase IIb KEYNOTE-942/mRNA-4157-P201 study. In the study, the combination of mRNA-4157/V940 and Keytruda led to a 44% reduction in the risk of disease recurrence or death against Keytruda alone as an adjuvant treatment for the above-mentioned patient group. Moderna and Merck plan to discuss these results with regulatory authorities and also intend to start a phase III study in melanoma patients next year and thereafter to expand to other cancer types.
Merck began enrolment in a new phase III program with investigational once-daily HIV candidate islatravir in combination with doravirine. While two new phase III studies began enrolling participants in February, two other phase III studies are expected to begin enrolment in March. The FDA had put a clinical hold on islatravir studies for HIV in 2021. In the new studies, Merck will evaluate a lower dose of islatravir than was used in studies put on hold.
Merck’s phase III study evaluating Lagevrio for post-exposure prophylaxis of COVID-19 infection failed to demonstrate a statistically significant reduction in the risk of the disease following household exposure to another individual with COVID-19. Lagevrio is approved or authorized in several markets for the treatment of certain adults who have been diagnosed with COVID-19.
Pfizer’s RSV Vaccine BLA for Maternal Immunization Gets FDA’s Priority Tag: Pfizer announced that the FDA has accepted its biologics license application (BLA) seeking approval of its RSV vaccine candidate, RSVpreF for the prevention of lower respiratory tract disease caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals. With the FDA granting priority review to the BLA, a decision is expected in August 2023. Pfizer’s BLA seeking approval of the RSV vaccine for older adults is already under priority review, with the FDA decision expected in May. The vaccine candidate is also under review for both older adults and maternal immunization in Europe.
The FDA also granted priority review to Pfizer’s BLA for investigational BCMA-CD3-targeted bispecific antibody, elranatamab, for the treatment of relapsed or refractory multiple myeloma. The FDA’s decision is expected this year. The European Medicines Agency also accepted elranatamab’s marketing authorization application.
AstraZeneca Gets EU Approval for Imfinzi+Imjudo Combo for Lung & Liver Cancers: The European Commission approved a combination of AstraZeneca’s cancer drugs, Imfinzi plus Imjudo (tremelimumab), combined with platinum-based chemotherapy, for treating adult patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC). This approval for the Imfinzi+Imjudo combo was based on data from the phase III POSEIDON study. Imfinzi plus Imjudo was approved by the FDA for this patient group in November.
The European Commission also approved Imfinzi+Imjudo for first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma, the most common type of liver cancer. The approval was based on positive data from the HIMALAYA phase III study. Imfinzi plus Imjudo was approved by the FDA for this patient group in October.
The European Commission also approved a new tablet formulation of Calquence for the chronic lymphocytic leukemia (CLL) indication. The approval was based on data from the ELEVATE-PLUS study. At present, Calquence is approved as a capsule formulation for CLL in the EU. The tablet formulation is already approved in the United States for all approved indications, CLL, small lymphocytic lymphoma and relapsed or refractory mantle cell lymphoma.
AstraZeneca announced a global exclusive license agreement with KYM Biosciences for the development and commercialization of CMG901, an antibody drug conjugate targeting Claudin 18.2, a therapeutic target in gastric cancer. CMG901 is currently being developed in a phase I study for the treatment of Claudin18.2-expressing solid tumors, including gastric cancer. It has shown early signs of anti-tumor activity in the study, across the dose levels tested. For the deal, AstraZeneca will make an upfront payment of $63 million to KYM Biosciences, with the latter also being entitled to additional development and sales-related milestone payments of up to $1.1 billion.
The NYSE ARCA Pharmaceutical Index rose 0.5% in the last five trading sessions.
Here’s how the eight major stocks performed in the last five trading sessions.
Image Source: Zacks Investment Research
In the last five trading sessions, Merck rose the most (3.8%), while Pfizer declined the most (1.5%).
In the past six months, Merck has risen the most (22.9%), while Pfizer declined the most (10.8%).
(See the last pharma stock roundup here: FDA Nod to PFE Cibinqo for Adolescents, Updates From NVO, RHHBY)
What’s Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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