This week, an FDA committee recommended updated booster shots of the COVID-19 vaccine to fight the Omicron variant. The European Commission (EC) approved
Sanofi’s ( SNY Quick Quote SNY - Free Report) two new drugs, Nexviadyme (avalglucosidase alfa) and Xenpozyme (olipudase alfa) as well as the expanded use of Merck’s ( MRK Quick Quote MRK - Free Report) Keytruda and Novartis’ ( NVS Quick Quote NVS - Free Report) Cosentyx. Pfizer ( PFE Quick Quote PFE - Free Report) signed a new COVID-19 vaccine supply deal with the U.S. government. The FDA granted Breakthrough Therapy Designation (BTD) to J&J’s ( JNJ Quick Quote JNJ - Free Report) multiple myeloma candidate, talquetamab Recap of the Week’s Most Important Stories The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to recommend the FDA Committee Recommends Redesigning COVID Boosters to Target Omicron: updated COVID-19 vaccine boosters that target the Omicron variant and its subvariants to improve vaccine effectiveness. The VRBPAC committee voted 19-2, recommending the modification of the current strain composition of available COVID-19 vaccines by incorporating genetic material from the Omicron variant in the modified boosters. If the FDA follows the VRBPAC’s recommendation, which it usually does, vaccine makers, Pfizer/BioNTech and Moderna will need to roll out modified boosters of their vaccines. Pfizer/BioNTech and Moderna are already developing Omicron-based COVID-19 vaccine boosters to address the rise of new and evolving Omicron subvariants. These Omicron-targeted vaccines have shown promise in clinical studies.
However, the vote did not specify if the modified boosters should target the Omicron variant or both the Omicron as well as the older ancestral strains of the virus. It was also not clear whether the modified boosters will target the more recent Omicron subvariants, BA.4 and BA.5, which represent more than half of all U.S. COVID-19 cases now.
The EC approved Sanofi’s Sanofi Gets Approval for Two New Drugs in Europe: two new enzyme replacement therapies, Nexviadyme (avalglucosidase alfa) and Xenpozyme (olipudase alfa).
While Nexviadyme was approved for the treatment of both late-onset Pompe disease and infantile-onset Pompe disease, a rare degenerative muscle disorder, Xenpozyme (olipudase alfa) was approved for the treatment of adult and pediatric patients with non-Central Nervous System manifestations of acid sphingomyelinase deficiency (ASMD), a rare, progressive, and potentially life-threatening genetic disease.
Avalglucosidase alfa is already approved in the United States, Japan, Canada, Switzerland, Australia, Brazil, Taiwan and the United Arab Emirates in the name of Nexviazyme. Xenpozyme is already approved in Japan for ASMD. An application seeking approval for olipudase alfa is under review in the United States, with a decision expected next week.
Merck’s Keytruda and Novartis’ Cosentyx Win Approvals for Expanded Use in Europe The EC also approved Merck’s blockbuster cancer drug, Keytruda, for : expanded use in the melanoma indication. Keytruda is now approved as an adjuvant treatment for adults and adolescent patients with stage IIB or IIC melanoma and who have undergone complete resection. Apart from stage IIB or IIC melanoma, the EC approved a label expansion of Keytruda to include adolescent patients aged 12 years and older with advanced melanoma and stage III melanoma (as adjuvant treatment following complete resection). The drug is already approved for these advanced disease stages in adults in Europe.
The EC approved Novartis’ blockbuster arthritis drug,
Cosentyx (secukinumab) for a new indication. The EC has now approved Cosentyx alone or in combination with methotrexate in the juvenile idiopathic arthritis categories of enthesitis-related arthritis and juvenile psoriatic arthritis in patients aged six years and above whose disease has responded inadequately to, or who cannot tolerate conventional therapy. Pfizer announced a new agreement with the U.S. government to supply 105 million doses of its COVID-19 vaccine for a payment of $3.2 billion Pfizer’s New COVID Vaccine Supply Deal with U.S. Government:
The deal includes its Omicron-adapted COVID-19 jabs if they are granted Emergency Use Authorization by the FDA. The first 105 million doses are expected to be delivered into the fourth quarter of this year. The deal also includes an option to purchase up to 195 million additional doses, bringing the total number of potential doses to 300 million.
Pfizer has already shared data from studies on its two Omicron-adapted vaccine candidates with regulators, including the FDA, and a request for EUA is planned.
The FDA granted BTD to J&J’s pipeline candidate, talquetamab, for heavily pre-treated patients with relapsed or refractory multiple myeloma. Talquetamab is a first-in-class bispecific antibody T-cell engager using GPRC5D, a novel target for the treatment of patients with relapsed or refractory multiple myeloma. The designation is based on data from the phase I/II MonumenTAL-1 study. FDA’s Breakthrough Tag for Novel Multiple Myeloma Candidate:
The NYSE ARCA Pharmaceutical Index rose 3.5% 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
All the stocks were in the green in the last five trading sessions. Roche rose the most (5.5%).
In the past six months, Merck rose the most (20.7%) while Roche declined the most (19.1%).
(See the last pharma stock roundup here:
FDA OK’s Expanded Use of ABBV, MRK, NVS Drugs, Other Updates) What's Next in the Pharma World?
Watch for regular pipeline and regulatory updates next week.