This week, the FDA granted full approval to
Pfizer ( PFE Quick Quote PFE - Free Report) and BioNTech’s COVID-19 vaccine, Comirnaty. The companies also initiated submission of phase III data to the FDA to seek a full approval for its COVID-19 vaccine booster shot. J&J ( JNJ Quick Quote JNJ - Free Report) released data supporting use of the booster shot. The European Commission granted approval for expanded use of Pfizer and AbbVie’s ( ABBV Quick Quote ABBV - Free Report) JAK inhibitor drugs, Xeljanz and Rinvoq, respectively. Recap of the Week’s Most Important Stories The FDA granted approval to Pfizer/BioNTech’s biologics license application (BLA) for their mRNA-based COVID-19 vaccine, Comirnaty. The vaccine, which was so far approved for emergency/conditional use, has now been granted “ FDA’s Full Approval to Pfizer/BioNTech’s COVID-19 Vaccine: full” approval to prevent COVID-19 in individuals 16 years of age and older. Comirnaty becomes the first COVID-19 vaccine, which has been granted full approval by the FDA. The full approval of Pfizer’s vaccine is expected to boost Americans’ confidence in the safety and efficacy of the vaccine, which should boost vaccination rates.
Pfizer and BioNTech have also initiated filing of a supplemental BLA (sBLA), seeking approval for a “booster” or
the third dose of Comirnaty. The sBLA for the booster dose includes data from a phase III study (n=306), which showed that the booster dose induced significant SARS-CoV-2 neutralizing antibody titers. The antibody levels elicited against the initial SARS-CoV-2 virus (wild type) one month after booster dose were 3.3 times the levels seen one month after the second dose. The companies plan to complete the sBLA filing by the end of this week.
Pfizer announced a definitive agreement to
buy small cancer biotech, Trillium for an equity value of $2.26 billion, or $18.50 per share, in cash. The acquisition will add Trillium’s two lead molecules, TTI-622 and TTI-621, which are in phase I/IIb development across several cancer indications, with a focus on hematological malignancies. : The European Commission granted approval to Pfizer’s JAK inhibitor drug, European Approvals for Expanded Labels of JAK Inhibitor Drugs Xeljanz for the treatment of active polyarticular juvenile idiopathic arthritis (polyarticular JIA) and juvenile psoriatic arthritis (juvenile PsA). Xeljanz is now approved for four indications in the EU, rheumatoid arthritis (RA), active PsA, moderately to severely active ulcerative colitis (UC) and now polyarticular JIA and juvenile PsA.
The EC also approved AbbVie’s JAK inhibitor drug, Rinvoq (upadacitinib) for the treatment of both adults and adolescents with
moderate-to-severe atopic dermatitis (AD). The approval for the AD indication marks the fourth EC-approved indication for Rinvoq. However, in the United States Rinvoq is only approved for treating moderate-to-severe rheumatoid arthritis (RA).
JAK inhibitor drugs are facing trouble in the United States as the FDA has delayed its decisions on label expansion filings for both Xeljanz and Rinvoq due to the ongoing review of Pfizer's post-marketing study, ORAL Surveillance, evaluating its marketed JAK inhibitor drug, Xeljanz (tofacitinib) in patients with RA.
J&J released data from two phase I/IIa studies evaluating a booster shot of its single-shot vaccine. The data showed that its COVID-19 vaccine booster, after the single dose primary regimen, provided J&J Study Shows Booster COVID Jab Increases Antibody Levels: rapid and robust increase in spike-binding antibodies. These antibody levels were nine-fold higher than 28 days after the primary single-dose vaccination.
The FDA approved expanded use of J&J and
Bayer’s ( BAYRY Quick Quote BAYRY - Free Report) blood thinner, Xarelto in Peripheral Artery Disease (PAD) indication. Xarelto can now be prescribed to patients who have recently undergone lower-extremity revascularization (LER) due to symptomatic PAD. The expanded approval is based on data from the phase III VOYAGER PAD study. A phase III study (FoCus) on AstraZeneca’s Wilson Disease Candidate Succeeds in Phase III: AstraZeneca’s ( AZN Quick Quote AZN - Free Report) pipeline candidate, ALXN1840, to treat Wilson disease met the primary endpoint by demonstrating statistically significant improvement in copper mobilization from tissues. In the study, copper mobilization from tissues was approximately three times greater for ALXN1840 than standard-of-care treatments. Wilson disease is a rare and progressive genetic condition in which the patient suffers from copper accumulation and related liver complications as the body’s pathway for removing excess copper is compromised. Merck’s Vaxneuvance Vaccine Study in Infants Meets Goal: Merck’s ( MRK Quick Quote MRK - Free Report) new 15-valent pneumococcal conjugate vaccine, Vaxneuvance, met the primary immunogenicity and safety endpoints in phase III pivotal study (PNEU-PED) evaluating its use in infants (42-90 days of age). The data showed that Vaxneuvance’ safety profile was generally comparable to the 13-valent pneumococcal conjugate vaccine (PCV13). Vaxneuvance was non-inferior to PCV13 for all 13 shared serotypes at 30 days following the third dose in the series based on serotype-specific response rates.
Merck’s blockbuster PD-L1 medicine, Keytruda was approved for two new indications in Japan, PD-L1-positive, hormone receptor-negative and HER2-negative, inoperable or recurrent breast cancer, and unresectable, advanced or recurrent high microsatellite instability (MSI-H) colorectal cancer. Keytruda is now approved for 15 indications in Japan, including indications in nine tumor types as well as MSI-H tumors.
Novartis Kymriah NHL Study Fails: Novartis’ ( NVS Quick Quote NVS - Free Report) phase III BELINDA study evaluating Kymriah as second-line treatment in aggressive B-cell non-Hodgkin lymphoma (NHL) failed to meet its primary endpoint of event-free survival compared to treatment with the standard-of-care (SOC). Kymriah is currently approved to treat certain advanced blood cancers in the third-line setting.
The NYSE ARCA Pharmaceutical Index declined 1.6% 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, all the stocks were in the red with Lilly declining the most (3.4%) while AbbVie was the only stock which rose (2.1%)
In the past six months, Pfizer has recorded the maximum gain (40.7%) while Novartis has seen the least gain (4.7%)
(See the last pharma stock roundup here:
FDA Nod for MRK, PFE Products & New Use of LLY, GSK Drugs)