This week the FDA announced delays in decisions on regulatory filings on atopic dermatitis JAK inhibitor drug candidates of
Pfizer ( PFE Quick Quote PFE - Free Report) , AbbVie ( ABBV Quick Quote ABBV - Free Report) and Lilly ( LLY Quick Quote LLY - Free Report) amid more scrutiny of JAK inhibitor class of drugs. Meanwhile, European regulators found a possible link between AstraZeneca’s ( AZN Quick Quote AZN - Free Report) COVID-19 vaccine and rare blood clot events. Recap of the Week’s Most Important Stories FDA Delays Decisions On AbbVie Rinvoq sNDA: The FDA extended review of AbbVie’s supplemental new drug application (sNDA) seeking approval of Rinvoq (upadacitinib) for a new indication —moderate-to-severe atopic dermatitis — by three months. The FDA’s decision is now expected in early third quarter. AbbVie had submitted information for an updated assessment of the benefit-risk profile for upadacitinib in atopic dermatitis per FDA’s request. The FDA needs the extra time to review the new data. Rinvoq is approved for treating moderate-to-severe rheumatoid arthritis in the United States. Regulatory applications seeking approval of Rinvoq for ankylosing spondylitis as well as active psoriatic arthritis are under review in the United States. Last month, the FDA also delayed a sNDA seeking approval of Rinvoq for active psoriatic arthritis by three months.
AbbVie submitted regulatory applications for Skyrizi (risankizumab) to the FDA and European Medicines Agency (EMA) for active psoriatic arthritis. Skyrizi is presently approved to treat plaque psoriasis while being evaluated in late-stage studies for psoriasis, Crohn's disease, ulcerative colitis.
On Lilly’s Olumiant sNDA: The FDA extended the review period of Lilly/Incyte’s sNDA for Olumiant in atopic dermatitis by three months. The FDA extended the review period as it needs time to review additional data submitted by Lilly on the agency’s request. The FDA’s decision is now expected in the third quarter of 2021. Olumiant is already approved in Europe and Japan for atopic dermatitis. Olumiant is presently approved to treat rheumatoid arthritis in several countries.
Meanwhile, a phase III study (BARRIER) evaluating Olumiant in hospitalized COVID-19 patients failed to show statistical significance on the primary endpoint of the proportion of participants progressing to non-invasive ventilation or death by Day 28. The data showed that patients who were treated with Olumiant were 2.7% less likely to progress to ventilation or death than those receiving standard of care,which is not a statistically significant improvement.
n Pfizer’s Filings for JAK Inhibitors: The FDA also extended the review period of Pfizer’s candidate abrocitinib in atopic dermatitis by three months. The FDA also extended the review period for Pfizer’s sNDA seeking approval of its marketed JAK inhibitor, Xeljanz for the treatment active ankylosing spondylitis (AS) by three months. The FDA’s decision on both the applications is now expected early in the third quarter of 2021.
The extension of review periods for sNDAs and other negative updates for JAK inhibitor drugs have raised concerns regarding safety issues of this class of drugs.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA) found a “possible link” between AstraZeneca’s Possible Link Between AstraZeneca’s COVID-19 Vaccine and Blood Clots: COVID-19 vaccine and extremely rare blood clot events.The World Health Organization (WHO) also said that a “casual relationship” between the vaccine and blood clot risk factors events is probable. However, all these regulatory bodies continue to maintain that that the vaccine’s benefits outweigh the risks. The U.S. government placed J&J Takes Full Charge of Emergent’s Vaccine Facility: J&J ( JNJ Quick Quote JNJ - Free Report) in chargeof its manufacturing partner Emergent’s Baltimore Bayview factory. A few weeks ago, reportedly, workers at Emergent's Bayview facility had mixed up vaccine ingredients of J&J’s and AstraZeneca’s vaccines. The incident reportedly ruined 15 million doses of J&J’s vaccine. U.S. health officials have now put J&J in charge of the facility, implying that the plant will now only make J&J’s vaccine to rule out any future mix-ups. The facility will cease production of AstraZeneca shots. J&J said that it will supervise and direct all critical manufacturing operations at the plant by increasing the number of manufacturing, quality and technical operations personnel at the facility. Merck’s Keytruda Succeeds in Adjuvant Kidney Cancer Study: Merck’s ( MRK Quick Quote MRK - Free Report) pivotal phase III study evaluating Keytruda as an adjuvant therapy in patients with renal cell carcinoma (RCC), a type of kidney cancer, following surgery, met its primary endpoint of disease-free survival (DFS). In the study (KEYNOTE-564), Keytruda demonstrated a statistically significant and clinically meaningfully improvement in DFS compared with placebo. The study will continue to evaluate OS, a key secondary endpoint. Keytruda is presently approved for use in combination with axitinib for the first-line treatment of patients with advanced RCC.
The NYSE ARCA Pharmaceutical Index was down 0.4% in the last five trading sessions.
Here’s how the eight major stocks performed in the last five trading sessions.
In the last five trading sessions, while Roche recorded the maximum gain (2.1%), Lilly declined the most (2.3%).
In the past six months, AbbVie recorded the maximum gain (20.1%) while AstraZeneca declined the most (10.5%).
(See the last pharma stock roundup here:
J&J, AZN COVID-19 Update, FDA Delays Decision on ABBV’s sNDA) What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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