FDA Updates for the Week of December 6, 2021

FDA grants emergency use of AstraZeneca’s COVID-19 prevention med.

FDA has issued an emergency use authorization (EUA) for AstraZeneca’s preventive COVID-19 monoclonal antibody Evusheld (tixagevimab co-packaged with cilgavimab and administered together).

Evusheld, the only antibody authorized in the United States for COVID-19 pre-exposure prophylaxis and the only COVID-19 antibody delivered as an intramuscular dose, will be available soon, AstraZeneca said in a statement.

The treatment is only authorized for adults and children 12 years and older who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to an individual infected with SARS-CoV-2, the FDA said in a statement. AstraZeneca is working quickly to establish Evusheld’s efficacy against the SARS-CoV-2 omicron variant.

FDA extends EUA of Pfizer/BioNTech Booster to those 16 and 17 years of age.

The FDA has authorized the use of Pfizer and BioNTech’s COVID-19 booster dose for adolescents 16 to 17 years of age, amending its emergency use authorization (EUA). The booster is given at least six months after completion of primary vaccination with the Pfizer-BioNTech COVID-19 vaccine to receive a booster dose, the agency said in a statement.

In late November, the FDA amended its emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines, authorizing the use of a single booster dose for all people 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine.

FDA approves therapy for multiple sclerosis-related spasticity.

The FDA has approved Saol Therapeutics’ Lyvispah (baclofen) oral granules for the treatment of patients 12 years of age or older with spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.

It is a strawberry-flavored, dissolvable granular formulation of baclofen and is available in 5mg, 10mg, and 20mg packets. Unlike other formulations of baclofen, it is approved for administration with or without water, with soft foods and with enteral feeding tubes.

Company officials expect full commercial launch in 2022.

FDA requires new boxed warning on Xeljanz, other JAK inhibitors.

The FDA is requiring an updated boxed warning on three top-selling Janus kinase (JAK) inhibitors used to treat rheumatoid arthritis and other inflammatory conditions. The new boxed warning applies to Pfizer’s Xeljanz (tofacitinib), Eli Lilly’s Olumiant (baricitinib), and AbbVie’s Rinvoq (upadacitinib).

The FDA previously warned about an increased risk of heart problems and cancer with Xeljanz, and in September, updated and expanded its warning to other JAK inhibitors.

The agency’s Drug Safety Communication said that, after reviewing of a large, randomized safety clinical trial, “we have concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with the arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR.”

The trial’s final results also showed an increased risk of blood clots and death with the lower dose of Xeljanz. A prior Drug Safety Communication based upon earlier results from this trial reported an increased risk of blood clots and death only seen at the higher dose. As a result, FDA required new and updated warnings on Olumiant and Rinvoq.

FDA committee votes no on bardoxolone for CKD.

The FDA’s Cardiovascular and Renal Drugs Advisory Committee has advised against approval of Reata Pharmaceuticals’ bardoxolone methyl for the treatment of patients with chronic kidney disease (CKD) caused by Alport syndrome. The committee indicated that the provided evidence does not demonstrate that bardoxolone is effective in slowing the progression of CKD and that its benefits outweigh its risks.

Reata officials said they will continue to work closely with the agency to provide additional information and data until the upcoming Prescription Drug User-Fee Act date of Feb. 25, 2022.

Secura Bio withdraws U.S. oncology indications for Copiktra, Farydak

Secura Bio has voluntarily withdrawn oncology indications for two of its therapies. The company has withdrawn the U.S. indication of Copiktra (duvelisib) for the treatment of patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies.

The relapsed or refractory FL indication received accelerated approval in September 2018 with the requirement that an additional confirmatory trial be conducted in order for the product to be granted full approval.

Company officials stressed this is a business decision and is not related to any changes in either the efficacy or safety associated with the therapy but with the logistics, cost and timing of the postmarketing requirements.

This decision impacts only the relapsed or refractory follicular lymphoma indication and does not affect other approved indications in the United States and other countries, including the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior therapies.

In addition, Secura Bio has withdrawn the NDA approval of Farydak (panobinostat), which received accelerated approval in February 2015 for use in combination with bortezomib and dexamethasone to treat patients with multiple myeloma who have received at least two prior regimens. Secura Bio acquired the therapy in March 2019.

In its withdrawal submission, Secura Bio noted that, as previously discussed with FDA, it was not feasible for the company to complete the required postapproval clinical studies as designed as part of the accelerated approval process. Secura Bio and its partners will continue to market Farydak in other markets where it has been approved.