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Attention Biotech Investors: Mark Your Calendar For These August PDUFA Dates

Attention Biotech Investors: Mark Your Calendar For These August PDUFA Dates

Though light in terms of PDUFA events, July yielded mostly positive results. Quiet a few approvals came through, including Eli Lilly And Co (NYSE: LLY)'s nasally administered low blood sugar drug, Karyopharm Therapeutics Inc (NASDAQ: KPTI)'s Selinexor and a handful of generic drugs.

With three new molecular entity approvals in July, the total number of NME approvals this year rose to 15, which pales before the 25 approvals that came through the same time last year.

PDUFA dates are deadlines for the FDA to review new drugs. The FDA is normally given 10 months to review new drugs. If a drug is selected for priority review, the FDA is allotted six months to review the drug. These time frames begin on the date that an NDA is accepted by the FDA as complete.

Here are the key PDUFA catalysts for the upcoming month.

Kala Eyes Drug Approval

  • Company: Kala Pharmaceuticals Inc (NASDAQ: KALA)
  • Type of Application: NDA
  • Candidate: KPI-121, 0.25%
  • Indication: dry eye disease
  • Date: Aug. 15

KPI-121, 0.25%, is Kala's candidate for the temporary relief of signs and symptoms of dry eye disease using a two-week course therapy. It will likely also work for dry eye flare.

The company said its product candidate, if approved, will be the first safe and effective short-term treatment option for dry eye disease.

Related Link: The 5 Most Expensive Drugs In US: What You Should Know

Vanda Sleepless Over Jet Lag Disorder Approval

  • Company: Vanda Pharmaceuticals Inc. (NASDAQ: VNDA)
  • Type of Application: sNDA
  • Candidate: Hetlioz
  • Indication: jet lag disorder
  • Date: Aug, 16

Vanda's Hetlioz is a melatonin receptor agonist, which was initially approved in 2014 to treat non-24-hour sleep-wake disorder in totally blind individuals.

Non-24 is a chronic body clock disorder in the blind that causes problems with the timing of sleep.

The company's sNDA for the drug was accepted in December of 2018, with the PDUFA date fixed for Aug. 16. However, the company said July 22 it received a notification from the FDA that the sNDA has deficiencies that preclude discussion of labeling and post-marketing requirements/commitments, although the agency did not disclose what the deficiencies were.

The FDA, however, said the notification does not reflect a final decision on the information under review.

Roche Seeks Approval For Personalized Cancer Medicine

  • Company: Roche Holdings AG Basel ADR (OTC: RHHBY)
  • Type of Application: NDA
  • Candidate: Entrectinib
  • Indication: solid tumors and non-small cell lung cancer, or NSCLC
  • Date: Aug. 18

Entrectinib is being evaluated for treating adult and pediatric patients with neurotrophic tropomyosin receptor kinase, or NTRK, fusion-positive locally advanced or metastatic solid tumors as well as for the treating people with metastatic, ROS1-positive NSCLC.

"By combining comprehensive genomic profiling with actionable targeted therapies, like entrectinib, we are advancing our personalised healthcare goal to find the right treatment for each patient," the company said in its release announcing FDA acceptance of the NDA.

Will Nabriva's Antibiotic Pass The FDA Muster?

  • Company: Nabriva Therapeutics PLC – ADR (NASDAQ: NBRV)
  • Type of Application: NDA
  • Candidate: intravenous and oral formulations of Lefamulin
  • Indication: community-acquired bacterial pneumonia, or CABP
  • Date: Aug. 19

Lefamulin is a semi-synthetic pleuromutilin antibiotic evaluated for CABP. The NDAs – for the IV and oral formulations – have a priority review status, Fast Track designations as well as Qualified Infectious Disease Product designations.

While accepting the application, the FDA said it hasn't planned an advisory committee meeting to discuss the applications.

AbbVie's Rheumatoid Arthiritis Drug

  • Company: AbbVie Inc (NYSE: ABBV)
  • Type of Application: NDA
  • Candidate: upadacitinib
  • Indication: rheumatoid arthritis
  • Date: Q3 (likely Aug. 19/20 assuming a six-month review period)

AbbVie's upadacitinib is an investigational once-daily JAK1-selective inhibitor being studied for multiple immune-mediated diseases. The company is now seeking approval of the drug for treating adult patients with moderate to severe rheumatoid arthritis.

Sarepta Seeks Approval Of Drug For DMD Patients With Specific Mutations

  • Company: Sarepta Therapeutics Inc (NASDAQ: SRPT)
  • Type of Application: NDA
  • Candidate: Golodirsen
  • Indication: Duchenne muscular dystrophy, or DMD
  • Date: Aug. 19

Golodirsen is being studied for the treatment of exon 53 amenable patients, who account for about 8% of DMD patients. It's a phosphodiamidate morpholino oligomer engineered to treat DMD patients who have generic mutations, subject to skipping exon 53 of the dystrophin gene.

Can Second Time Be Charm For IntelliPharmaCeutics?

  • Company: IntelliPharmaCeutics International Inc. (OTC: IPCIF)
  • Type of Application: NDA
  • Candidate: Rexista
  • Indication: abuse-deterrent pain medication
  • Date: Aug. 28

Rexista is Oxycodone Hydrochloride extended-release tablets. The FDA issued a complete response letter to the original NDA in September of 2017, with the agency providing recommendations and requesting for information, including the relevant Category 2 and Category 3 studies to assess the abuse-deterrent properties of Oxycodone ER by the oral and nasal routes of administration.

The company resubmitted the application March 4, 2019, with the FDA accepting the resubmitted application on March 29, deeming it to be a complete response.

Nektar Waits With Bated Breath For Opioid Pain Medication Approval

  • Company: Nektar Therapeutics (NASDAQ: NKTR)
  • Type of Application: NDA
  • Candidate: NKTR-181
  • Indication: chronic low back pain in adult patients new to opioid therapy
  • Date: Aug. 29

NKTR-181 is a novel mu-opioid analgesic drug candidate. On July 23, the company said it received a General Advice letter from the FDA regarding its NDA, communicating the postponement of an Adcom meeting scheduled for Aug. 21, as the regulatory agency continues to consider a number of scientific and policy issues relating to this class of drugs.

Although the postponement is not unique to NKTR-181, the FDA did say in the communication the PDUFA goal date may not be met.


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