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Pharma Stock Roundup: New Warning Order by FDA for JAK Drugs, & Pipeline Updates

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This week, the FDA ordered a new warning about an increased risk of serious heart-related events, cancer, blood clots, and even death to be added to the labels of JAK inhibitor medicines, Pfizer’s PFE Xeljanz, Lilly’s LLY Olumiant, and AbbVie’s ABBV Rinvoq. Pfizer. Meanwhile, Sanofi SNY, Merck MRK, J&J JNJ, and Roche RHHBY came up with updates on their pipeline.

Recap of the Week’s Most Important Stories

FDA Requires Heart-Risk Warnings on JAK Inhibitor Drugs’ Labels: The FDA ordered warnings about an increased risk of serious heart-related events, cancer, blood clots, and even death to be added on the labels of three JAK inhibitor medicines, Pfizer’s Xeljanz/Xeljanz XR, Lilly/Incyte’s Olumiant (baricitinib) and AbbVie’s Rinvoq (upadacitinib), which are approved to treat certain chronic inflammatory conditions. The FDA’s decision followed its review of safety data from Pfizer’s post-marketing study, ORAL Surveillance, on Xeljanz in patients with rheumatoid arthritis (“RA”).

The FDA’s review of the final data from the study showed that patients treated with both low as well as high doses of Xeljanz experienced a higher rate of serious heart-related events such as heart attack and stroke, cancer, blood clots, and death compared to those treated with another class of drugs —TNF inhibitors. Previously, the FDA thought that only a higher dose of Xeljanz would increase such risks. The FDA required the warnings to be added not just to Xeljanz’s label but also on Olumiant and Rinvoq as they share the same mechanism of action as Xeljanz and so may carry similar risks as identified in Xeljanz’ssafety study.

J&J’s HIV Vaccine Study Fails: J&J’s mid-stage study on HIV vaccine showed that its vaccine candidate did not provide a sufficient level of protection against HIV infection in young women in sub-Saharan Africa. The study showed a 25.2% vaccine efficacy, based on which the company decided that it will not be continued. However, the vaccine was found to be safe and no vaccine-related safety signals were identified. Meanwhile, the global phase III Mosaico HIV study evaluating a different composition of the vaccine regimen will continue.

The FDA approved J&J’s Invega Hafyera (6-month paliperidone palmitate), a long-acting version of its schizophrenia medicines, Invega Sustenna (a one-month formulation of paliperidone palmitate) and Invega Trinza (three-month formulation). Invega Hafyera is the first and only medicine approved as a twice-yearly treatment for adults with schizophrenia.

Roche Withdraws mTNBC Indication for Tecentriq: Roche voluntarily withdrew the U.S. indication for its blockbuster PD-L1 inhibitor drug, Tecentriq, for PD-L1-positive, metastatic triple-negative breast cancer (mTNBC). The decision was taken in consultation with the FDA, which the latter suggested after assessing the current mTNBC treatment landscape and the requirements of the accelerated approval program. Roche gained accelerated approval for Tecentriq for the mTNBC indication in 2019. However, continued approval for the indication was contingent upon the results of IMpassion131 study on Tecentriq for the first-line treatment of people with mTNBC in the PD-L1-positive population. The study did not meet the primary endpoint of PFS.

Sanofi/Regeneron’s Dupixent Study in Kids Meets Goal: A pivotal study evaluating Sanofi/Regeneron’s blockbuster medicine, Dupixent to treat moderate-to-severe atopic dermatitis (“AD”) in children aged 6 months to five years met all primary and secondary endpoints. In the study, Dupixent significantly reduced overall disease severity and improved skin clearance and itch in this patient group at 16 weeks compared to TCS alone. The data showed that of the patients treated with Dupixent plus topical corticosteroids (TCS), 28% experienced clear or almost clear skin (the primary endpoint) compared to 4% with placebo. Dupixent plus TCS reduced overall disease severity by 70% and itch by 49%. Dupixent is presently approved to treat moderate-to-severe AD in patients aged 6 years and older as well as two other type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis in adults and severe asthma in patients 12 years and older.

Pfizer’s Abrocitinib Beats Dupixent in Eczema Head-to-Head Study: Pfizer announced top-line data from the phase III head-to-head JADE DARE study comparing the efficacy of its investigational JAK inhibitor drug, abrocitinib to Dupixent for moderate-to-severe AD. The study met its co-primary and key secondary efficacy endpoints. Top-line data from the study showed that abrocitinib was statistically superior compared to Dupixent in each evaluated efficacy measure.

Pfizer began a phase III study (RENOIR) on its respiratory syncytial virus (RSV) vaccine candidate in older adults aged 60 or older.

Merck Begins Late-Stage Study on Molnupiravir for COVID Prevention: Merck and partner Ridgeback Biotherapeutics announced the initiation of a pivotal phase III study (MOVe-AHEAD) for evaluating its oral investigational therapeutic molnupiravir for post-exposure prophylaxis of COVID-19 infection. The study is enrolling people who reside in the same household as someone who has laboratory-confirmed COVID infection with symptoms. Molnupiravir is currently being evaluated in a phase III study (MOVe-OUT) for the treatment of non-hospitalized patients with confirmed mild-to-moderate COVID-19, data from which is expected in the second half.

The FDA approved the conversion of Merck’s approval for Keytruda for the first-line advanced urothelial carcinoma (bladder cancer) indication in the United States from an accelerated approval to a full one. Meanwhile, it also allowed the locally advanced or metastatic urothelial carcinoma (mUC) indication to be revised to allow it for use in those patients who are not eligible for any platinum-containing chemotherapy. Previously, the indication was mUC in patients who were not eligible for cisplatin-containing chemotherapy and whose tumors expressed PD-L1 (Combined Positive Score [CPS] ≥10) or in patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. The accelerated approval was based on the KEYNOTE-052 study with the final approval contingent on data from the KEYNOTE-361 study. Although the KEYNOTE-361 study failed to meet its co-primary endpoints, progression-free survival, and overall survival, the FDA’s Oncologic Drugs Advisory Committee meeting, earlier this year, voted in favor of maintaining the accelerated approval of Keytruda for its first-line bladder indication.

The NYSE ARCA Pharmaceutical Index rose 0.03% in the last five trading sessions.

Large Cap Pharmaceuticals Industry 5YR % Return

Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return

Large Cap Pharmaceuticals Industry 5YR % Return

Here’s how the eight major stocks performed in the last five trading sessions.

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Zacks Investment Research


Image Source: Zacks Investment Research

In the last five trading sessions, AstraZeneca rose the most (1.4%) while AbbVie declined the most (7%)

In the past six months, Pfizer has recorded the maximum gain (36.9%) while AbbVie has seen the least gain (6.0%)

(See the last pharma stock roundup here: PFE’s COVID Jab Full Approval by FDA, JNJ’s Booster Data)

What's Next in the Pharma World?

Watch out for regular pipeline and regulatory updates next week.


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