FDA Action Alert: Nabriva, Seattle Genetics, Sarepta and Nektar


Wrapping up the month of August, there are technically four PDUFA dates on the calendar, although one was approved two months early and another may be delayed as the U.S. Food and Drug Administration (FDA) reevaluates its policies regarding opioid pain medications. Here’s a look.

Nabriva Therapeutics and its Antibiotic Lefamulin

Nabriva Therapeutics has a target action date of August 19 for both its intravenous (IV) and oral formulations of lefamulin. Lefamulin is a potentially first-in-class, semi-synthetic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Both applications were granted priority review, as well as Fast Track designation and Qualified Infectious Disease Product (QIDP) designation.

The two New Drug Applications (NDAs) are built on two pivotal, Phase III clinical trials, LEAP 1 and LEAP 2, that compared the two formulations of lefamulin to moxifloxacin in adults with CABP. The drug has also been approved for review by the European Medicines Agency (EMA).

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Seattle Genetics’ Polivy for Large B-Cell Lymphoma

In a bit of an unusual move, the FDA approved Seattle Genetics Polivy (polatuzumab vedotin-piiq), an antibody-drug conjugate (ADC) targeting CD79b on June 10, two months ahead of its target action date of August 19. Polivy was approved in combination with bendamustine plus Rituxan (rituximab) for adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least two previous therapies.

Polivy was developed with and will be commercialized by Genentech. In Europe it was granted PRIME designation for the same indication. It was approved by the FDA under a Breakthrough Therapy Designation.

An ADC is a monoclonal antibody linked to a cancer-killing agent.

“The approval of Polivy under our collaboration with Genentech is an important milestone for Seattle Genetics as it extends the reach of our technology to more patients with significant unmet medical needs,” stated Clay Siegall, president and chief executive officer of Seattle Genetics, in June. “This approval, along with our own internal ADCs in development and those of other collaborators, such as GlaxoSmithKline, highlights that ADCs continue to grow as an important therapeutic approach to treating both hematologic malignancies and solid tumors.”

Sarepta Therapeutics’ Vyondys 53 for Duchenne Muscular Dystrophy

Sarepta Therapeutics has a target action date of August 19 for Vyondys 53 (golodirsen). Golodirsen is a phosphordiamidate morpholino oligomer engineered to treat DMD patients who have genetic mutations subject to skipping exon 53 of the dystrophin gene. This is comparable to the company’s Exondys 51, which is a treatment for DMD in patients amenable to skipping exon 51 of the DMD gene.

DMD is a fatal genetic neuromuscular disorder that affects mostly boys. It affects an estimated one in every 3,500 to 5,000 males worldwide.

The company completed its NDA at the end of 2018 as part of a rolling submission and requested priority review, which was granted. It had previously been granted orphan drug designation.

“If approved, golodirsen will serve up to another 8% of the Duchenne community, bringing us closer to helping as many Duchenne patients as possible,” stated Doug Ingram, Sarepta’s president and chief executive officer, in February.

Nektar Therapeutics NKTR-181 Opioid Pain Killer

Nektar Therapeutics has a target action date of August 29 for its NDA for NKTR-181, a first-in-class opioid analgesic for chronic low back pain in adults new to opioid therapy. In February 2019, the FDA informed the company that it was extending the review period by three months to allow time to review data from two additional preclinical studies Nektar conducted after the agency requested them in an earlier review process.

At the company’s second-quarter financial report on August 8, it stated, “InN July, for NKTR-181, Nektar received a General Advice Letter from FDA that stated that it is postponing product-specific advisory committee meetings for opioid analgesics, including the one previously scheduled for August 21, 2019 to discuss the NDA for the NKTR-181 product, while the agency continues to consider a number of scientific and policy issues relating to this class of drugs. The FDA indicated that it will continue to review the NDA for NKTR-181 according to the existing Prescription Drug User Fee Act timeline; however, because of the postponed Advisory Committee Meeting, it is possible the agency may not be able to meet the PDUFA goal date of August 29, 2019.”

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