Pfizer Eucrisa Label Expansion, And Other News: The Good, Bad And Ugly Of Biopharma – Citybizlist Real Estate

Pfizer Receives FDA Nod for Eucrisa Label Expansion

Pfizer (PFE) reported that the FDA has granted approval for the expanded use of its lead drug Eucrisa. The Supplemental New Drug Application for the drug pertained to the extension of lower age limit from 24 months to 3 months in children suffering from mild to moderate atopic dermatitis. This condition is also known as eczema. The drug was earlier approved to be used by adults and children 2 years and older.

With this approval Eucrisa is the only steroid free topical prescription medication available in the market for treating patients as young as 3 months of age. Atopic Dermatitis is a chronic skin ailment and manifests itself as inflammation of the skin. Early onset AD starts within two years of life, with 45 percent of the cases beginning within the first six months of life. Richard Blackburn, Global President, Inflammation & Immunology, Pfizer, "We are committed to making a meaningful difference to patients lives, and with this indication extension, we look forward to now helping many of the youngest children suffering with eczema." It is estimated that the condition affects approximately 18 million people.

Pfizer provided data from a Phase 4, open-label, clinical study aimed to assess the safety of crisaborole ointment in children aged 3 months to less than 24 months suffering from mild-to-moderate AD for supporting its sNDA. The main exploratory endpoint of the study was to measure the effectiveness of the drug. The ointment was found to be well tolerated and it demonstrated effectiveness without showing nay new safety signals.

Phase 4 CrisADe CARE 1 trial was a four-week, multicenter, open-label, single-arm study evaluated the safety of crisaborole ointment, 2%, applied twice daily in 137 pediatric patients. A cohort of 21 of the 137 subjects was included in a subgroup for pharmacokinetic (PK) assessment, with clinical diagnoses of moderate AD and a minimum of 35% treatable %BSA, excluding the scalp.

Gilead Receives Orphan Drug Label, Restricts Emergency Access

Gilead Sciences (GILD) reported that the FDA has granted Orphan Drug Status for COVID 19 treatment to its Remdesivir. This status grants a number of benefits such as seven year period of market exclusivity for specific indications, if approved. The drug candidate also goes through accelerated evaluation process, making it possible to launch it in the market in a shorter period of time.

Remdesivir had been used for COVID 19 treatment on compassionate basis in Europe and in the United States. However, due to high demand, the company had to halt emergency access to the drug. The company cited exponential increase in demand as the main reason behind this move. However, Gilead will be exempting pregnant women and children under 18 with severe COVID 19 from this ban. A company statement said that the demand, flooded an emergency treatment access system that was set up for very limited access to investigational medicines and never intended for use in response to a pandemic.

Gilead is looking at alternatives such as expanded access programs instead of the current individual patient pathway. The company stated that the alternative will allow it not only supply the medicine to needy patients but also to collect pertinent data. Gilead is collaborating with regulators world over to fructify these programs.

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Pfizer Eucrisa Label Expansion, And Other News: The Good, Bad And Ugly Of Biopharma - Citybizlist Real Estate