UK reg­u­la­tor warns of se­vere eye re­ac­tions fol­low­ing use of Sanofi and Re­gen­eron's Dupix­ent

The UK’s Med­i­cines and Health­care Reg­u­la­to­ry Agency (MHRA) on Tues­day warned of some new and se­ri­ous eye-re­lat­ed side ef­fects fol­low­ing the use of Sanofi and Re­gen­eron’s atopic der­mati­tis and asth­ma treat­ment Dupix­ent (dupilum­ab).

While Dupix­ent is al­ready as­so­ci­at­ed with cas­es of con­junc­tivi­tis and al­ler­gic con­junc­tivi­tis, dry eye and with in­fre­quent cas­es of ker­ati­tis and ul­cer­a­tive ker­ati­tis, the MHRA is call­ing on health pro­fes­sion­als to be on the look­out for any of these eye-re­lat­ed side ef­fects as “it is not cur­rent­ly pos­si­ble to pre­dict who may ex­pe­ri­ence the rar­er and most se­vere oc­u­lar ad­verse re­ac­tions, such as ul­cer­a­tive ker­ati­tis.”

De­spite the new warn­ing, ex­pert oph­thal­mol­o­gy and der­ma­tol­ogy ad­vice pro­vid­ed to the MHRA in­di­cat­ed that most oc­u­lar re­ac­tions seen with dupilum­ab are mild and man­age­able.

“It is there­fore im­por­tant, with all oc­u­lar re­ac­tions, for pa­tients to re­ceive prompt care, with treat­ment pro­vid­ed as ap­pro­pri­ate to pre­vent or min­imise dam­age to the eye. It is im­por­tant to recog­nise ‘red flags’ for ur­gent oph­thal­mo­log­i­cal con­sul­ta­tion, such as eye pain, vi­sion loss, and an in­crease in oc­u­lar pres­sure,” the MHRA said.

The block­buster Dupix­ent was first li­censed in the UK in Sep­tem­ber 2017 in those old­er than 12 years for mod­er­ate to se­vere atopic der­mati­tis and as add-on main­te­nance treat­ment for se­vere asth­ma.

As of Sept. 7, the MHRA says it has re­ceived 479 UK re­ports which in­clud­ed sus­pect­ed oc­u­lar side ef­fects with dupilum­ab. Of those, 111 re­ports were con­sid­ered se­ri­ous, MHRA said, not­ing that nine re­ports of ul­cer­a­tive ker­ati­tis were re­ceived, rep­re­sent­ing five cas­es, and two of these cas­es in­volved corneal per­fo­ra­tion. 18 re­ports in­volved chil­dren rang­ing from 6 to 17 years of age.

But the UK reg­u­la­tors al­so not­ed that of­ten­times treat­ment does not have to be dis­con­tin­ued, not­ing:

UK clin­i­cal ex­pe­ri­ence is that dupilum­ab treat­ment does not usu­al­ly need to be dis­con­tin­ued in the event of oc­u­lar re­ac­tions. It is im­por­tant for the pa­tient to re­ceive time­ly ad­vice and in­ter­ven­tion with ap­pro­pri­ate care and man­age­ment of oc­u­lar re­ac­tions, and for pa­tients and health­care pro­fes­sion­als to recog­nise se­ri­ous re­ac­tions, and when oph­thal­mo­log­i­cal re­fer­ral is nec­es­sary.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Post-hoc analy­sis: EMA's CHMP re­jects Ipsen's po­ten­tial drug for rare ge­net­ic dis­ease

The European Medicines Agency’s Committee for Medicinal Products for Human Use on Friday rejected Ipsen Pharma’s potential treatment for a rare genetic disease known as fibrodysplasia ossificans progressiva (FOP), which causes extra bone to form outside the skeleton.

The EMA said on its website that it could not draw any firm conclusions on the benefits of the French biopharma’s Sohonos (palovarotene), which selectively targets the retinoic-acid receptor gamma (RARγ), “as the applicant’s conclusion was based on a post-hoc analysis which was neither scientifically nor clinically justified and pre-specified study objectives were not met.”

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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.